The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantab...
FDA Device Recall #Z-0346-2020 — Class II — November 16, 2018
Recall Summary
| Recall Number | Z-0346-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 16, 2018 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | LivaNova USA Inc |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 9282 |
Product Description
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 implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagus nerve by the lead. The lead and the generator make up the implantable portion of the VNS Therapy System. The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy programming software and a programming wand. The physician uses the programming system to read and change generator settings. The Model 1000 Generator was commercially approved for distribution in the U.S. on October 3, 2017 via PMA P970003/S210.
Reason for Recall
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 Pattern
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, Italy, Netherlands, Norway, Portugal, Sweden
Lot / Code Information
Serial Numbers Less Than 100000
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-0561-2020 | Class I | VNS Therapy, SenTiva, Model # 1000, (01)0542502... | Aug 22, 2019 |
| Z-1118-2020 | Class II | VNS Therapy SENTIVA Generator Model # 1000 ... | Aug 13, 2019 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
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.