Northridge, CA, United States
Medtronic Inc. recalls
38 recalls recorded since 2018, most recently on 11 March 2026. 25 are listed as ongoing. Status and classification are as published by the FDA.
Recalls38
Ongoing (FDA)25
Terminated or completed13
Class I (FDA)6
Ongoing Class II Medical devices
- Recall started
- 11 March 2026
- Reason
- Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1948-2026
- Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Ongoing Class II Medical devices
- Recall started
- 4 December 2025
- Reason
- Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
- Distribution
- Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Thailand, United Arab
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1098-2026
- Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Ongoing Class II Medical devices
- Recall started
- 29 October 2025
- Reason
- There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0726-2026
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
Ongoing Class II Medical devices
- Recall started
- 18 June 2025
- Reason
- In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
- Distribution
- Worldwide - US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2168-2025, Z-2169-2025
- Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software M
- Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Software Model Number D00U005; 2. Claria Amplia Compia application, Software Mod
Ongoing Class II Medical devices
- Recall started
- 17 June 2025
- Reason
- A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2127-2025, Z-2128-2025
- Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena Solara ap
- Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Percepta Serena So
Ongoing Class II Medical devices
- Recall started
- 29 April 2025
- Reason
- Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or system revision (explant/replacement) leading to infection, hematoma, or temporary impairment.
- Distribution
- International distribution of the country of UK. No US distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1924-2025
- Azure S DR MRI SureScan, Product number W3DR01
Ongoing Class II Medical devices
- Recall started
- 11 July 2024
- Reason
- Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3152-2024
- 2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product De
Ongoing Class II Medical devices
- Recall started
- 16 April 2024
- Reason
- Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Mol
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2197-2024, Z-2206-2024, Z-2190-2024, Z-2209-2024, Z-2210-2024, Z-2205-2024, Z-2207-2024, Z-2211-2024, Z-2202-2024, Z-2208-2024, Z-2200-2024, Z-2204-2024 and 11 more
- EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator
- COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator
- COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator
- Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator
- COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator
- MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator
- COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator
- CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator
- and 15 more product lines
Ongoing Class II Medical devices
- Recall started
- 16 February 2024
- Reason
- There is a potential for sterile package breach.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirates, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1317-2024
- Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Ongoing Class II Medical devices
- Recall started
- 7 December 2023
- Reason
- During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.
- Distribution
- US Nationwide distribution in the state of Florida.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0779-2024
- Cobalt XT DR MRI SureScan Implantable Cardioverter Defibrillator, product number DDPA2D1
Completed Class II Medical devices
- Recall started
- 20 November 2023
- Reason
- Seal defects could compromise the ability of the product packaging to maintain sterility.
- Distribution
- US Nationwide distribution in the state of MN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0623-2024
- Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Ongoing Class II Medical devices
- Recall started
- 3 November 2023
- Reason
- It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.
- Distribution
- US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Macao, Malaysia, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Puerto Rico, Saudi Ar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0421-2024
- ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Ongoing Class II Medical devices
- Recall started
- 12 October 2023
- Reason
- The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0321-2024, Z-0322-2024, Z-0320-2024
- Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
- Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
- Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Ongoing Class II Medical devices
- Recall started
- 14 July 2022
- Reason
- Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
- Distribution
- worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1644-2022
- EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
Ongoing Class II Medical devices
- Recall started
- 24 June 2022
- Reason
- Luer has balloon diameter printed as "2.25mmx12mm" instead of the correct diameter, "2.5mmx12mm" as reflected on the product outer packaging.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1483-2022
- Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounted on its distal tip.
Ongoing Class I Medical devices
- Recall started
- 5 May 2022
- Reason
- Batteries for the HVAD system have a weld defect affecting internal components within the HVAD battery, resulting in the battery to malfunction and no longer provide power or prevent the battery from holding a complete charge or properly recharging.
- Distribution
- Worldwide Distribution. US nationwide, Austria, Belgium, Finland, France, Germany, Hungary, Italy, Netherlands, New Zealand, North Macedonia, Norway, Poland, Spain, Switzerland, and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1266-2022
- HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Ongoing Class I Medical devices
- Recall started
- 14 April 2022
- Reason
- The pump may have a welding defect that can lead the pump to malfunction. The issue is under investigation by the firm. It is suspected that a weld defect on the center post cap may allow moisture into the center post and corrode the magnets that keep the impeller rotating concentrically, leading to unintended contact between the center post and impeller. If this occurs, it may affect blood flow through the pump. The issue may present clinical signs and symptoms that resemble pump thrombosis.
- Distribution
- Worldwide distribution - US Nationwide DE and TX. There was no military/government distribution. The countries of Germany and Japan.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1207-2022
- HeartWare HVAD Pump Implant Kit, a) Model Number 1104JP, b) Model Number MCS1705PU
Ongoing Class II Medical devices
- Recall started
- 30 March 2022
- Reason
- Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.
- Distribution
- Worldwide Distribution: US (nationwide) and OUS to countries of: Australia, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, INDIA, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Poland, Slovakia, South Africa, Spain, Switzerland, Turkey, United Kingdom
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1110-2022
- Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1
Ongoing Class I Medical devices
- Recall started
- 2 March 2022
- Reason
- There is potential for the capsule bond to break during the procedure.
- Distribution
- US Nationwide and the countries of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0927-2022
- Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Terminated Class III Medical devices
- Recall started
- 23 March 2021
- Terminated
- 4 August 2026
- Reason
- Firm received increased number of reports that VenaSeal dispensing systems are not effectively advancing the adhesive forward through the delivery catheter.
- Distribution
- Distributed nationwide to MA, NY, VT, NH, ME
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1564-2021
Terminated Class II Medical devices
- Recall started
- 16 March 2021
- Terminated
- 15 April 2024
- Reason
- Incorrect size printed on the device; packaging is labeled correctly.
- Distribution
- US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1532-2021
- Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.
Ongoing Class II Medical devices
- Recall started
- 26 February 2021
- Reason
- Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1606-2021, Z-1602-2021, Z-1613-2021, Z-1609-2021, Z-1601-2021, Z-1612-2021, Z-1614-2021, Z-1617-2021, Z-1615-2021, Z-1603-2021, Z-1605-2021, Z-1610-2021 and 8 more
- Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabet
- Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtron
- Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtr
- Medtronic REF: MMT-7020C3 Guardian Sensor (3) for the following packaging: GS3 5PK OUS3/ GTIN: 20643169704118 GS3 5PK 9L OUS3/ GTIN: 20763000243368 GS3 5PK 9L OUS3/ GTIN: 20763000318882 Product Usage: intended
- Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Diabetes (Medtroni
- Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended fo
- Medtronic REF: MMT-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic Diabetes (Medtron
- Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems t
- and 12 more product lines
Ongoing Class II Medical devices
- Recall started
- 12 November 2020
- Reason
- Incomplete basal rate information may be transmitted leading to a potential for inappropriate change in therapy. During data upload, radio frequency (RF) interference can occur at any point from surrounding devices or equipment that may affect the data transfer between the insulin pump and the CareLink Personal or CareLink System Software.
- Distribution
- U.S. Nationwide O.U.S. Worldwide Refer to Associated Documents and uploaded Consignee Lists/Spreadsheets. -Australia New Zealand -Canada -EMEA -Greater China -India -Japan -Latin America -South Korea -Southeast Asia -US
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0843-2021
- CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Management Software Tool for Diabetes Software Uploader versions: 3.1.5.000 3.1.2.000
Terminated Class II Medical devices
- Recall started
- 15 July 2020
- Terminated
- 18 February 2022
- Reason
- As a result of the release of new software version to CareLink Personal website, the IOS app for the Continuous Monitoring Glucose system stopped automatically uploading data to the website.
- Distribution
- International distribution including in the countries of EMEA - Austria, Belgium, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Kuwait, Latvia, Luxembourg, The Netherlands, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Sl
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2980-2020
- The Guardian Connect App CSS7200 iOS - Product Usage: intended for use by patients with a compatible consumer mobile device.
Completed Class II Medical devices
- Recall started
- 13 July 2020
- Reason
- The previous software application version (1.1.300) is missing a decimal separator (a comma) for parameter range guidance values displayed on some of the programming screens: Catheter, Reservoir, Infusion, Bolus, myPTM, and Alarm.
- Distribution
- Foreign Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0522-2024
- Medtronic SynchroMed, Model A10
Ongoing Class II Medical devices
- Recall started
- 30 April 2020
- Reason
- Missing solder battery connection, which could interrupt power of insulin pump.
- Distribution
- Worldwide distribution - U.S. Nationwide Distribution in the state of MD and the countries of Canada, Netherlands, Norway. ***Model 630G distributed in Canada and Model 670G distributed in US ***MODEL640G Distributed OUS ONLY*** OUS: Australia, Canada, Netherlands and Norway.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0516-2021, Z-0518-2021, Z-0517-2021
- MiniMed 670G, insulin pump, Ref/Model # MMT-1760KPK, MMT-1762KCN, MMT-1762WWK - Product Usage: indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and
- MiniMed 640G, insulin pump, Ref/Model # MMT-1711K, MMT-1752K, MMT-1752, Rx Only - Product Usage: indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in per
- MiniMed 630G with SmartGuard, insulin pump, Ref/Model # MMT-1754K, MMT-1714K, MMT-1755K - Product Usage: intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses
Terminated Class II Medical devices
- Recall started
- 10 April 2020
- Terminated
- 27 April 2021
- Reason
- Internal testing results showed endotoxin-related test result did not meet specifications for implantable insulin pump. If pumps have higher than allowed endotoxin levels, patients may have an effect of fever, hypotension, anaphylactic shock, hyperglycemia, or diabetic ketoacidosis (DKA), potentially followed by secondary multi-organ failure (primarily renal and hepatic) and/or death.
- Distribution
- No US Distribution. OUS: Netherlands, France, and Sweden
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2206-2020
- Medtronic Implantable Insulin Pump System, REF: MMT-2007D, Sterile EO, CE 0459 UDI: 00763000043001
Ongoing Class II Medical devices
- Recall started
- 28 January 2020
- Reason
- Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen
- Distribution
- Worldwide distribution - US Nationwide and countries Australia, Canada, New Zealand, India, Korea, Japan, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Latin America, France, Switzerland. Italy, Belgium, Germany, Netherlands, Denmark, Poland, Austria, Czech Republic, Croatia, Spain, Finland,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1408-2020
- McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a to
Ongoing Class I Medical devices
- Recall started
- 21 November 2019
- Reason
- There have been reported incidents of a loose reservoir that can no longer be locked into the pump. The reservoir can become loose due to a broken or missing retainer ring that prevents a proper lock. If the reservoir is not properly locked into the pump, it could lead to over or under delivery of insulin, which could then result in hypoglycemia or hyperglycemia.
- Distribution
- US:AK,AL,AR,AZ,BM,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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY OUS: France, Germany, UK, Italy, Netherlands, Spain, Sweden, Israel, Norway, Austria, Belgium, Denmark, Czech Repub
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0955-2020, Z-0958-2020, Z-0957-2020, Z-0956-2020
- Medtronic MiniMed 630G System with SmartGuard, Ref/Model # MMT-1515, MMT-1715, MMT-1714, MMT-1754, and MMT-1755 *US and Canada Version Only
- Medtronic MiniMed 640G Insulin Infusion Pump, Ref#s/Model(s) - MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, and MMT-1752 *Not for US Distribution
- Medtronic MiniMed 620G Insulin Infusion Pump, Ref #s/Model(s) - MMT-1510, MMT-1710, and MMT-1750 *Not Distributed within the US
- Medtronic MiniMed 670G System with SmartGuard, Ref #s/Model Number(s) - MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, and MMT-1782
Terminated Class II Medical devices
- Recall started
- 21 May 2019
- Terminated
- 7 October 2020
- Reason
- Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1884-2019, Z-1881-2019, Z-1880-2019, Z-1882-2019, Z-1883-2019
- Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
- Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Ongoing Class II Medical devices
- Recall started
- 20 May 2019
- Reason
- Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2106-2020
- Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.
Ongoing Class II Medical devices
- Recall started
- 3 October 2018
- Reason
- Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens. This could cause a user to miss system notifications, alarms or sirens associated with how the pump is working, and with high and low glucose alerts.
- Distribution
- US: 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, Puerto Rico, RI, VT, SC, SD, TN, TX, UT, VA, Virgin Island, VT, WA, WI, WV, and WY
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0683-2019
- Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
Terminated Class I Medical devices
- Recall started
- 7 August 2018
- Terminated
- 29 March 2024
- Reason
- There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
- Distribution
- Distribution was nationwide to consumers and distributors. There was no government/military distribution. Foreign distribution was made to Algeria, Australia, Austria, Belgium, Brazil, Canada, China, Croatia, Czech Republic, Denmark, Estonia, Faroe Islands, Finland, France, Germany, Greece, Hu
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0178-2020, Z-0177-2020
- Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-522K/722K, MMT-515/71
- Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin Pump (MMT-508).
Terminated Class II Medical devices
- Recall started
- 4 July 2018
- Terminated
- 6 June 2022
- Reason
- The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter resulting in the user not receiving alerts that could be associated with hypoglycemic or hyperglycemic events.
- Distribution
- Distribution was only made OUS. Countries involved are: Austria, United Arab Emirate, Australia, Belgium, Switzerland, Chile, Colombia, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Hungary, Ireland, Israel, Iceland, Italy, Republic of Korea, Luxembourg, Netherlands, No
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1282-2019
- Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Terminated Class II Medical devices
- Recall started
- 16 May 2018
- Terminated
- 30 June 2020
- Reason
- CONTOUR PLUS LINK 2.4 meter with an incorrect unit of measure was included into meter kits and distributed. This meter contains the incorrect unit of measure mg/dL instead of mmol/L.
- Distribution
- International Distribution to Slovakia only.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3201-2018
- Contour Plus Link 2.4, Product Catalog Number: MMT-1151SK. wireless blood glucose monitoring system Contour Plus LINK 2.4 wireless blood glucose monitoring system (glucometer, test strips and control solution) is des
Terminated Class II Medical devices
- Recall started
- 24 April 2018
- Terminated
- 2 May 2022
- Reason
- The MiniMed Paradigm Veo insulin pump has an error that impacts the Arabic language translation.This translation error occurs in the Predictive Alerts setting screen, which allows user to program alerts that will sound if users are predicted to reach their pre-set low or high sensor glucose values.
- Distribution
- International only. No U.S. distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2377-2018
- Medtronic MiniMed Paradigm Veo Insulin Pump Product Catalog Number: MMT-554, MMT-754
Terminated Class II Medical devices
- Recall started
- 10 October 2017
- Terminated
- 26 March 2021
- Reason
- Due to a time conversion error, data uploaded from the iPro(TM)2 recorder to the CareLink iPro software using the new CareLink iPro Uploader feature may result in incorrect reports. This pertains only to reports generated between September 23, 2017 and September 27, 2017 that used the new CareLink iPro Uploader feature.
- Distribution
- Worldwide Distribution - US Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0670-2018
- Medtronic CareLink iPro Therapy Management Software, MMT-7340 The CareLink iPro Therapy Management Software (model, MMT-7340) is intended to be used by a healthcare professional (HCP) with the iPro2 CGM System and pro
Terminated Class I Medical devices
- Recall started
- 26 September 2017
- Terminated
- 27 April 2021
- Reason
- Complaints regarding 6F Taiga guide catheter tip detachment and/or tip splitting.
- Distribution
- Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1207-2018
- 6F Taiga Guiding Catheter
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.