VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS...
FDA Device Recall #Z-0561-2020 — Class I — August 22, 2019
Recall Summary
| Recall Number | Z-0561-2020 |
| Classification | Class I — Serious risk |
| Date Initiated | August 22, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | LivaNova USA Inc |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 1687 |
Product Description
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Reason for Recall
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 Pattern
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
Lot / Code Information
Implanted devices with Serial Numbers Greater Than or Equal to 100000 that did not undergo the internal error screen.
Other Recalls from LivaNova USA Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0535-2021 | Class II | VNS Therapy SENTIVA DUO # 1000-D - Product Usag... | Nov 12, 2020 |
| Z-0462-2021 | Class II | VNS Therapy¿ AspireSR¿ Generator | Sep 28, 2020 |
| Z-1563-2020 | Class II | VNS Therapy Programmer, Model 3000 used with Mo... | Feb 4, 2020 |
| Z-1118-2020 | Class II | VNS Therapy SENTIVA Generator Model # 1000 ... | Aug 13, 2019 |
| Z-0663-2020 | Class II | VNS Therapy Program GMDN: 44077 Model # 3000 V1... | Nov 16, 2018 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.