Minneapolis, MN, United States
Medtronic Neuromodulation recalls
46 recalls recorded since 2018, most recently on 13 May 2026. 39 are listed as ongoing. Status and classification are as published by the FDA.
Recalls46
Ongoing (FDA)39
Terminated or completed7
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 13 May 2026
- Reason
- A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
- Distribution
- Worldwide distribution - US Nationwide and The countries of Austria, France, Germany, Italy, Japan, Latvia, Netherlands, Poland, Spain, Sweden, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2240-2026, Z-2241-2026
- Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
- Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
Ongoing Class II Medical devices
- Recall started
- 8 April 2026
- Reason
- Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2201-2026
- Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU
Ongoing Class II Medical devices
- Recall started
- 3 December 2025
- Reason
- Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1043-2026
- A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
Ongoing Class II Medical devices
- Recall started
- 20 November 2025
- Reason
- Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Aruba, Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Finland, France, French Pol
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0996-2026
- Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TAB
Ongoing Class II Medical devices
- Recall started
- 3 April 2025
- Reason
- Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
- Distribution
- US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1704-2025
- Enhanced Verify Evaluation Handset (CFN HH90130FA)
Ongoing Class II Medical devices
- Recall started
- 4 March 2025
- Reason
- There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
- Distribution
- Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of: Austria, Belgium, Bulgaria, Canary Islands, Cyprus, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Japan, Luxembourg, Malta, Netherlands, Northern Ireland, Norway, Poland,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1543-2025
- Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
Ongoing Class II Medical devices
- Recall started
- 9 January 2025
- Reason
- Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Portugal, Puerto Rico, Spain, Sweden, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1506-2025
- A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Ongoing Class II Medical devices
- Recall started
- 21 November 2024
- Reason
- Software issues were identified in application version 2.x.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0773-2025, Z-0772-2025, Z-0771-2025, Z-0774-2025
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
- SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
Ongoing Class II Medical devices
- Recall started
- 24 September 2024
- Reason
- A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
- Distribution
- International distribution to the countries of Germany, UK, and Israel.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0206-2025
- Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
Ongoing Class II Medical devices
- Recall started
- 18 September 2024
- Reason
- The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0372-2025
- Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 97
Ongoing Class II Medical devices
- Recall started
- 11 September 2024
- Reason
- Potential for error and inability to interrogate pump due to data corruption in the pump memory.
- Distribution
- US Nationwide distribution in the state of Mississippi.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0137-2025
- SynchroMed II Infusion Pump. Product Number: 8637-20
Ongoing Class II Medical devices
- Recall started
- 21 August 2024
- Reason
- Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0132-2025
- Vanta Implantable Neurostimulator (INS), Model 977006
Ongoing Class II Medical devices
- Recall started
- 17 June 2024
- Reason
- A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3073-2024
- Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the Model HH90 Handset and the TM90 Communicator.
Ongoing Class II Medical devices
- Recall started
- 15 May 2024
- Reason
- Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Belgium, Bolivia, Brazil, Canada, Canary Islands, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Is
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2427-2024
- A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Ver
Ongoing Class II Medical devices
- Recall started
- 10 May 2024
- Reason
- Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
- Distribution
- Worldwide Distribution: US (nationwide) and OUS (foreign) countries of: Argentina, Aruba, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile, Colombia, Cyprus, Czech Rep, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Guadeloupe, Germany, Greece,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2352-2024
- Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revision kit)
Ongoing Class II Medical devices
- Recall started
- 28 March 2024
- Reason
- inability to reprogram one device
- Distribution
- International distribution in the country of UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1691-2024
- Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
Ongoing Class II Medical devices
- Recall started
- 19 December 2023
- Reason
- Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
- Distribution
- Germany
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0780-2024
- Model A710 Intellis Clinician Programmer Application, version 2.0.97
Ongoing Class II Medical devices
- Recall started
- 13 November 2023
- Reason
- Medtronic recently identified that if the SynchroMed II pump switches into telemetry mode due to electromagnetic interference (EMI) from an MRI scan, while the pump is sounding an alarm, the pump will not resume drug delivery after leaving the MRI magnetic field, which is inconsistent with the current labeling.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0614-2024, Z-0615-2024
- Medtronic SynchroMed II, Model 8637-20, Programmable pump
- Medtronic SynchroMed II, Model 8637-40, Programmable pump
Ongoing Class II Medical devices
- Recall started
- 19 October 2023
- Reason
- Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
- Distribution
- International distribution to the countries of S. Korea and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0354-2024
- Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Ongoing Class II Medical devices
- Recall started
- 6 July 2023
- Reason
- Lot of InterStim Self-Adhesive Ground Pad is being recalled due to the product being labeled with the incorrect expiration date.
- Distribution
- International distribution to the country of Iran.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2365-2023
- Medtronic InterStim Ground Pad REF 041826
Ongoing Class II Medical devices
- Recall started
- 21 June 2023
- Reason
- When an update to the A710 Clinician Programmer software application for the Intellis Neurostimulation System was released, the corresponding version of the A901 Communication Manager software application was not available for download.
- Distribution
- International distribution to the countries of Israel and Serbia.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2226-2023
- A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
Ongoing Class II Medical devices
- Recall started
- 6 June 2023
- Reason
- A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue from patients implanted with a Vanta INS, both of which have resulted in explant procedures.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2036-2023
- Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation
Ongoing Class II Medical devices
- Recall started
- 17 March 2023
- Reason
- Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1408-2023
- Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
Ongoing Class II Medical devices
- Recall started
- 20 January 2023
- Reason
- Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0121-2024
- SenSight Connector Plug, Model Number B31061.
Ongoing Class II Medical devices
- Recall started
- 3 December 2022
- Reason
- Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0913-2023, Z-0915-2023, Z-0912-2023, Z-0914-2023, Z-0911-2023
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900E
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900B
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900D
- Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900A
Ongoing Class II Medical devices
- Recall started
- 26 July 2022
- Reason
- Potential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta Implantable Neurostimulator (INS) Model 977006 when a patient is implanted with more than one neurostimulator.
- Distribution
- Worldwide distribution - US distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and Puerto Rico. The countries of Aus
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1574-2022
- Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Ongoing Class II Medical devices
- Recall started
- 26 July 2022
- Reason
- Potential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user will be unable to perform programming of the Vanta Implantable Neurostimulator (INS) Model 977006.
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Puerto Rico. The countrie
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1571-2022
- Vanta Clinician Programmer Application, Model A71200. For programming of the Medtronic Model 977006 Vanta implantable neurostimulators for pain therapy.
Completed Class II Medical devices
- Recall started
- 27 May 2022
- Reason
- There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
- Distribution
- US: MO, FL, TX, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0217-2024
- LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Ongoing Class II Medical devices
- Recall started
- 30 March 2022
- Reason
- The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Italy, Sweden,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1123-2022
- Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.
Ongoing Class II Medical devices
- Recall started
- 30 March 2022
- Reason
- The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of Arge
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1129-2022, Z-1128-2022
- Percept PC BrainSense Implantable Neurostimulator (INS) Model B35200
- Percept BrainSense Implantable Neurostimulator (INS), Model B35200
Terminated Class II Medical devices
- Recall started
- 28 February 2022
- Terminated
- 30 September 2026
- Reason
- There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.
- Distribution
- US Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY, AR, MO, MN, OH, CO, KS, MS, SC, LA, WA, PA, IN, SD, MI, WV, AL, GA, TN, VA, IA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0998-2022
- MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Th
Ongoing Class II Medical devices
- Recall started
- 4 November 2021
- Reason
- The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.
- Distribution
- US Nationwide, including PR. There was government distribution but no military distribution was identified.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0295-2022, Z-0294-2022, Z-0293-2022
- Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI
- Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
- Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
Ongoing Class II Medical devices
- Recall started
- 19 October 2021
- Reason
- During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.
- Distribution
- Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Canada, Austria, Belgium, Canary Islands, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slo
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0418-2022
- Model B35200 - Percept PC BrainSense Implantable Neurostimulator
Ongoing Class II Medical devices
- Recall started
- 23 September 2021
- Reason
- A software anomaly may occur with the clinician programmer application.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, New Zealand, Canada, Europe, India, Japan, Korea, Middle East, Latin America, Africa, SE Asia and China.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0201-2022
- Clinician Programmer Application (CPA) model A610 Clinician Software Application
Ongoing Class II Medical devices
- Recall started
- 9 July 2021
- Reason
- Specific PINs of the Vectris SureScan MRI lead kits contain the incorrect lead electrode spacing information printed on the shelf box and the sterile pack labeling.
- Distribution
- Austria, Belgium, Brazil, Canary Islands, Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2159-2021
- Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
Ongoing Class II Medical devices
- Recall started
- 2 June 2021
- Reason
- Excess nylon flash on the clip.
- Distribution
- AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and Hawaii
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2228-2021
- Medtronic StimLoc Burr Hole Cover, Part Numbers: a) 3387S-40 b) 3389S-28 c) 3389S-40 d) 3391S-40 e) 3550S-01 f) 924256 g) DB-5000
Ongoing Class II Medical devices
- Recall started
- 25 March 2021
- Reason
- There is a potential for unintended heating that can occur with the Intellis Model 97755 Recharger.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1535-2021
- Intellis Model 97755 Recharger - Product Usage: designed to charge the following Medtronic rechargeable neurostimulators: Intellis with AdaptiveStim Technology Model 97715 Implanted Neurostimulator Intellis Model 977
Ongoing Class II Medical devices
- Recall started
- 9 March 2021
- Reason
- There are two issues within this correction action: 1. Cycling Issue: When copying settings from a previously used Activa device to a new Percept PC Implantable Neurostimulator (INS) using the "replacement" function of the A610 clinician programmer application, the cycling feature is not copied properly. 2. Log Fill Issue: When the Percept PC INS System Event log is full, the clinician programmer A610 Software application version 2.0.4584, 2.0.4594, 2.0.4605, or 3.0.1057 crashes when it attempts a reading of the last records in the log.
- Distribution
- Worldwide distribution - US Nationwide distribution in Puerto Rico and the countries of Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Japan, Lithuania, Luxembourg, Malaysia, Malta,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1368-2021
- A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.4605, and 3.0.1057* * Version 3.0.1057 i
Terminated Class II Medical devices
- Recall started
- 19 November 2020
- Terminated
- 3 April 2023
- Reason
- A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.
- Distribution
- US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0612-2021
- Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, d
Ongoing Class II Medical devices
- Recall started
- 12 November 2020
- Reason
- A710 Intellis Clinician Application has a software issue that can result in the inability to program the Intellis implantable neurostimulation device.
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Canada, Latin America, Asia Pacific, Japan, China, and European regions.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0860-2021
- Medtronic Intellis Spinal Cord Stimulator, Model Number A710, Clinical Programmer application version 1.3.80 - Product Usage: intended for use by clinicians in the programming of the following Medtronic neurostimulators
Terminated Class II Medical devices
- Recall started
- 17 July 2020
- Terminated
- 27 September 2024
- Reason
- The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.
- Distribution
- Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2657-2023
- Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
Terminated Class I Medical devices
- Recall started
- 11 October 2019
- Terminated
- 15 September 2023
- Reason
- There is a potential for the presence of a foreign particle inside the pump motor assembly which could interfere with the motor gear rotation and lead to a permanent motor stall.
- Distribution
- US and Canada, Asia -Pacific (APAC), China, Europe, Middle East and Africa (EMAE), Latin America (LATAM)
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0508-2020
- Synchromed II programmable pump, Model numbers 8637-20 and 8637-40
Ongoing Class II Medical devices
- Recall started
- 15 May 2019
- Reason
- There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).
- Distribution
- Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1774-2019
- InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator
Terminated Class II Medical devices
- Recall started
- 25 May 2018
- Terminated
- 11 December 2020
- Reason
- This voluntary recall is being conducted due to the curved tip introducer needle which is included in the kit, to have a potential manufacturing defect. This could result in difficulty advancing or withdrawing the Vectris lead through the curved tip introducer needle.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2431-2018, Z-2432-2018
- Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation, Models: (a) 977D160 (b) 977D260 Product Usage: The Medtronic Vectris lead kits contain the implantable spinal cord stimulation lead, as well as addi
- Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation, Models: (a) 977A160 (b) 977A175 (c) 977A190 (d) 977A260 (e) 977A275 (f) 977A290 Product Usage: The Medtronic Vectris lead kits contain the implan
Terminated Class III Medical devices
- Recall started
- 21 September 2017
- Terminated
- 20 March 2020
- Reason
- There is a possibility that specific lots of catheters that have recently been distributed may be at risk for an increased potential for kinking at the proximal end where the catheter connects to the drug infusion pump.
- Distribution
- Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0537-2018
- Medtronic Ascenda(R) Intrathecal Catheter, Models: (a) 8780, UDI: 00643169202122, 00643169783027 (b) 8781, UDI: 00643169202139 (c) 8784, UDI: 00643169202153 The Ascenda Intrathecal Catheter kits (models 8780, 87
Ongoing Class II Medical devices
- Recall started
- 9 August 2017
- Reason
- Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.
- Distribution
- US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0896-2018
- Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter. Product Usage: The implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and del
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.