Arvada, CO, United States
LivaNova USA Inc. recalls
23 recalls recorded since 2018, most recently on 3 January 2025. 5 are listed as ongoing. Status and classification are as published by the FDA.
Recalls23
Ongoing (FDA)5
Terminated or completed18
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 3 January 2025
- Reason
- Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue.
- Distribution
- Worldwide - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR,PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT and the countries of AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR,
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1067-2025, Z-1068-2025
- Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation (VNS), cons
- Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimulation
Ongoing Class II Medical devices
- Recall started
- 12 December 2024
- Reason
- Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
- Distribution
- US: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT. OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN, IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1072-2025, Z-1073-2025
- SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
- SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Terminated Class II Medical devices
- Recall started
- 2 December 2021
- Terminated
- 25 January 2024
- Reason
- A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomfort or pain due to delivery of stimulation to an unintended location. If the inner lead conductor is exposed to body fluids the lead may break causing loss of therapy.
- Distribution
- US: NE, MO, AR, WV, KS, MA, IN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0532-2022
- Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)
Terminated Class II Medical devices
- Recall started
- 12 November 2020
- Terminated
- 12 January 2023
- Reason
- During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
- Distribution
- International distribution in the countries of Austria and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0535-2021
- VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
Terminated Class II Medical devices
- Recall started
- 28 September 2020
- Terminated
- 2 November 2022
- Reason
- Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4.
- Distribution
- U.S.: AK, AL, AZ, CA, CO, DC, FL, HI, ID, IL, IN, KS, KY, LA, ME, MI, MN, MO, MT, NC, NE, NV, OK, OR, PR, TX, UT, VA, and WA O.U.S.: Argentina, Finland and Peru
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0462-2021
- VNS Therapy¿ AspireSR¿ Generator
Terminated Class II Medical devices
- Recall started
- 24 April 2020
- Terminated
- 17 February 2022
- Reason
- The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period.
- Distribution
- US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2457-2020, Z-2464-2020, Z-2456-2020, Z-2447-2020, Z-2448-2020, Z-2455-2020, Z-2453-2020, Z-2459-2020, Z-2461-2020, Z-2460-2020, Z-2451-2020, Z-2452-2020 and 10 more
- Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
- Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
- Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
- Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
- Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
- Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
- Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
- 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
- and 14 more product lines
Terminated Class II Medical devices
- Recall started
- 24 February 2020
- Terminated
- 4 August 2022
- Reason
- The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination.
- Distribution
- U.S. Nationwide distribution including Puerto Rico. This matter was triggered by the clearance of K191402, thus only the United States, including Puerto Rico, is affected. O.U.S. - none
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1498-2020
- LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less.
Ongoing Class II Medical devices
- Recall started
- 4 February 2020
- Reason
- False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower output current and widen pulse width. Only system diagnostic testing evaluates output current. Users may conclude device malfunction, could lead to medical/surgical intervention.
- Distribution
- U.S.: LA, ID, AZ, UT, KY, VA, TN, NY, SC, IL, IN, NC, WA, CA, OH, FL, PA, NJ, CO, TX, RI, MD, HI, OR, MA, NE, MO, OK, MS, MN, SD, VT, AR, WV, WI, MI, AL, KS, DE, NM, GA, ND, AK, MT, ME, NV, DC, MO, WY, IA, CT. Canada, and Israel.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1563-2020
- VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
Terminated Class III Medical devices
- Recall started
- 18 November 2019
- Terminated
- 19 August 2021
- Reason
- Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector.
- Distribution
- Distributed to medical facilities in 5 states including: Minnesota, Kansas, Missouri, Utah and Washington.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2642-2020
- LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Terminated Class I Medical devices
- Recall started
- 22 August 2019
- Terminated
- 28 March 2024
- Reason
- Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.
- Distribution
- U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR. OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT, SE, IT
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0561-2020
- VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Terminated Class II Medical devices
- Recall started
- 13 August 2019
- Terminated
- 18 May 2022
- Reason
- Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.
- Distribution
- US: FL, GA, KS, MO, and UT. No OUS distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1118-2020
- VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy
Terminated Class III Medical devices
- Recall started
- 3 July 2019
- Terminated
- 9 July 2021
- Reason
- Perfusion tubing pack was packaged with the incorrect cuvette.
- Distribution
- US Nationwide distribution in the state of IL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1389-2020
- LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used w
Terminated Class III Medical devices
- Recall started
- 28 January 2019
- Terminated
- 31 January 2022
- Reason
- Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd.
- Distribution
- US: NJ and CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1119-2020
- LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an oper
Ongoing Class II Medical devices
- Recall started
- 16 November 2018
- Reason
- This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 102 and Model 102R devices, if the output current is greater than 0.5mA. This can result in false high impedance values during patient follow-up.
- Distribution
- IL, AK, AL, AR, AZ, CA, CA , CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD MI, MN, MO, MS, MT, NC, ND, NE, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WA , WI, WV, WY,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0663-2020
- VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Ongoing Class II Medical devices
- Recall started
- 16 November 2018
- Reason
- Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software.
- Distribution
- US: PA, WV, KY, NY, MD, VA, DC, NC, GA, SC, NJ, DE, MA, OH, RI, CT, ME, NH, VT, IL, WI, IN, MO, MI, MN, SD, ND, NE,KS, IA, TX, OK, TN, MS, AL, FL, LA, ID, MT, WA, OR, UT, AK, AZ, AZ , CO, WY, NM, CA, HI, AR. Foreign (OUS): Austria, Switzerland, Germany, Denmark, Spain, Finland, United Kingdom, It
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0346-2020
- The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an im
Terminated Class II Medical devices
- Recall started
- 16 November 2018
- Terminated
- 12 December 2022
- Reason
- This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 generators. *Note this recall occurred in November 2018.
- Distribution
- Distribution US nationwide, including Puerto Rico. There was no foreign/military/government consignees.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0869-2020, Z-0868-2020
- Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
- Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
Terminated Class II Medical devices
- Recall started
- 9 November 2018
- Terminated
- 3 May 2022
- Reason
- 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded.
- Distribution
- Worldwide Distribution - Domestic (US) Consignees: AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WV, MS; Foreign (OUS) Consignees: Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0770-2019
- Perfusion Pack, Rx only, Sterile EO
Terminated Class II Medical devices
- Recall started
- 1 November 2018
- Terminated
- 4 August 2022
- Reason
- The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the 3T.
- Distribution
- Worldwide distribution - US Nationwide distribution including sate of PR and countries of Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmar
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0220-2020
- SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three se
Terminated Class II Medical devices
- Recall started
- 14 September 2018
- Terminated
- 14 September 2022
- Reason
- For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).
- Distribution
- US Distribution to states of: IN, MO, and OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1099-2019
- SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion
Terminated Class II Medical devices
- Recall started
- 20 April 2018
- Terminated
- 5 February 2025
- Reason
- Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm.
- Distribution
- MN, TX, WA, OR, IL, OH, SC, AK, PA, CA, WI, GA, NJ, FL, AZ, KY, MS, MO, LA, AR, MA, MI, MT, CO, TN, NE, NC, VA, NV, HI, PR, WY, AL, OK, IN, CT, ME, IA, SC, KS, NM, SD, DC, MD, ND,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1901-2018
- Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
Terminated Class II Medical devices
- Recall started
- 13 March 2018
- Reason
- Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed.
- Distribution
- US Distribution to the states of : NJ, CA, MN, MO, MA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1919-2018, Z-1918-2018
- Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenato
- Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator
Terminated Class II Medical devices
- Recall started
- 24 January 2018
- Terminated
- 29 November 2023
- Reason
- Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer.
- Distribution
- Distributed domestically to AZ, CA, GA, IA, IL, IN, MO, MT, NC, NY, PA, SD, TN, TX, WA, WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2572-2018
- VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Terminated Class III Medical devices
- Recall started
- 19 December 2017
- Terminated
- 11 August 2020
- Reason
- The product is labeled with the incorrect expiration date.
- Distribution
- Distribution was made to one consignee in LA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0664-2018
- Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
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.