LivaNova USA, Inc. recalls
Every recall we track for LivaNova USA, Inc. — 43 in all, from 2018–2025 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from LivaNova USA, Inc. peaked in 2020 (26); 43 since 2017. 5% rated “stop using now”.
All FDA recall records for LivaNova USA, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 1 | 6 | 0 | 7 |
| 2019 | 0 | 1 | 4 | 0 | 5 |
| 2020 | 2 | 0 | 17 | 7 | 26 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 2 | 0 | 0 | 2 |
| 2025 | 0 | 1 | 1 | 0 | 2 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled LivaNova USA, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All LivaNova USA, Inc. recalls
19 shown- Lower riskMedical device
LivaNova USA, Inc. recalls Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA
LivaNova USA, Inc. is a leading medical device manufacturer specializing in innovative solutions for cardiovascular and respiratory care. We provide advanced technologies to improve patient outcomes and quality of life.
LivaNova USA, Inc.Jan 3, 2025 - Use cautionMedical device
LivaNova USA, Inc. recalls SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve
LivaNova recalls SenTiva and SenTiva Duo vagus nerve stimulator generators with serial numbers under 500,000 that may stop delivering therapy, risking seizure return or surgery.
LivaNovaDec 12, 2024 - Lower riskMedical device
LivaNova USA, Inc. recalls Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode
LivaNova recalls VNS therapy leads model 303 due to potential silicone tubing wall thickness issues that could cause lead breach and discomfort or loss of therapy.
LivaNovaDec 2, 2021 - Lower riskMedical device
LivaNova USA Inc recalls VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in
LivaNova recalls SENTIVA DUO device model 1000-D with serial numbers 311298, 310443, 310068, 310353, 310531, 310351, 310380, 310348 due to incorrect model number display after reset.
LivaNovaNov 12, 2020 - Lower riskMedical device
LivaNova USA Inc recalls VNS Therapy¿ AspireSR¿ Generator
LivaNova recalls certain VNS Therapy AspireSR Generator devices with serial numbers containing an extra digit that may not work with software version 11.0.4. Affected units can be identified by specific serial numbers listed in the recall notice.
LivaNovaSep 28, 2020 - Lower riskMedical device
LivaNova USA Inc. recalls Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
LivaNova recalls sterile disposable connectors with specific lot numbers due to potential barrier breaches in packaging. Affected units may have compromised sterility during use.
LivaNovaApr 24, 2020 - Lower riskMedical device
LivaNova USA Inc. recalls LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat
LivaNova recalls Heater-Cooler 3T systems for potential NTM contamination during cardiopulmonary bypass procedures. Follow cleaning instructions to reduce risk.
LivaNovaFeb 24, 2020 - Lower riskMedical device
LivaNova USA Inc recalls VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
LivaNova recalls VNS Therapy Programmer Model 3000 (v1.6) used with specific VNS generators due to false positive warnings that may cause unnecessary medical procedures. Affected users should contact LivaNova for guidance.
LivaNovaFeb 4, 2020 - Lower riskMedical device
LivaNova USA Inc. recalls LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
LivaNova recalls sterile disposable connectors with a 3/8x1/4 reducer instead of 1/2x1/2. No health risk expected as the mismatched size prevents use.
LivaNovaNov 18, 2019 - Use cautionMedical device
LivaNova USA Inc recalls VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
LivaNova recalls SenTiva VNS therapy devices with serial numbers >= 100000 that may reset within 60 days, potentially requiring surgery or worsening symptoms.
LivaNovaAug 22, 2019 - Lower riskMedical device
LivaNova USA Inc recalls VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600
LivaNova recalls VNS Therapy SENTIVA Generator Model 1000 units that were sterilized with an extra cycle, which may not meet quality standards. Affected units have specific model labels and serial numbers.
LivaNovaAug 13, 2019 - Lower riskMedical device
LivaNova USA Inc. recalls LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in
LivaNova recalls SMART PERFUSION PACK INSPIRE 8S tubing packs with incorrect cuvette packaging. Affected units have model 046008200 and lot 19121:100141. No remedy specified in recall notice.
LivaNovaJul 3, 2019 - Lower riskMedical device
LivaNova USA Inc. recalls LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The
LivaNova recalls S5 systems with incorrect manufacturing date labels. Some devices show dates in yy-mm-dd format instead of yyyy-mm-dd. Affected units may have labeling errors that could cause confusion during use.
LivaNovaJan 28, 2019 - Lower riskMedical device
LivaNova USA Inc recalls Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC.,
Cyberonics recalls VNS Therapy AspireSR Model 106 generators with serial numbers 36519-43201 due to premature battery depletion from electrical leakage in circuit boards.
CyberonicsNov 16, 2018 - Lower riskMedical device
LivaNova USA Inc recalls The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy
LivaNova recalls VNS Therapy System generators with serial numbers less than 100,000 due to higher impedance readings during diagnostics, potentially causing incorrect settings. Affected users should contact for guidance.
LivaNovaNov 16, 2018 - Lower riskMedical device
LivaNova USA Inc recalls VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
LivaNova recalls VNS Therapy Program GMDN 3000 V1.5.2 software version devices that may display false high impedance values during patient follow-up due to a diagnostic test error.
LivaNovaNov 16, 2018 - Use cautionMedical device
LivaNova USA Inc. recalls SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an
LivaNova recalls SORIN Heater-Cooler System 3T models with potential disinfectant inefficiency and aerosol emission risks. Affected units may need repair or replacement to ensure patient safety during medical procedures.
LivaNovaNov 1, 2018 - Lower riskMedical device
LivaNova USA Inc. recalls SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or
LivaNova recalls six units of SORIN Heater-Cooler System 3T (REF 16-02-85) due to post-deep cleaning water testing positive for nontuberculous mycobacteria. Affected units have specific serial numbers.
LivaNovaSep 14, 2018 - Lower riskMedical device
LivaNova USA Inc recalls VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
LivaNova recalls VNS Therapy Programming System Model 3000 v1.0.2.2 due to unintended warning messages displayed on generators. Affected units have specific serial numbers and part numbers. No remedy is stated in the recall notice.
LivaNovaJan 24, 2018
LivaNova USA, Inc. recall questions
How many recalls has LivaNova USA, Inc. had?
43 recalls from LivaNova USA, Inc. are on record with U.S. safety agencies, from 2018–2025.
What is the most recent LivaNova USA, Inc. recall?
LivaNova USA, Inc. recalls Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA, dated Jan 3, 2025. Every LivaNova USA, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled LivaNova USA, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new LivaNova USA, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.