VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Us...
FDA Device Recall #Z-3019-2017 — Class II — June 13, 2017
Recall Summary
| Recall Number | Z-3019-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 13, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cyberonics, Inc |
| Location | Houston, TX |
| Product Type | Devices |
| Quantity | 396 units |
Product Description
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. Depression (PMA 970003/S050): VNS Therapy is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Indications outside the U.S.: Epilepsy (Non-US): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizure (with or without secondary generalization) or generalized seizures that are refractory to antiepileptic medications. AspireSR (Seizure Response) features the Automatic Stimulation Mode which is intended for patients who experience seizures that are associated with cardiac rhythm increases known as ictal tachycardia. Depression (Non-US): The VNS Therapy System is indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment-intolerant depressive episode.
Reason for Recall
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Distribution Pattern
Worldwide Distribution - US Nationwide and Puerto Rico and the following states: 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, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Puerto Rico. Distribution internationally to Argentina, Austria, Belgium, Canada, Croatia, Czech Republic, Finland, Germany, Ireland, Israel, Italy, Japan, Lebanon, Netherlands, Norway, Poland, Qatar, Saudi Arabia, United Arab Emirates, and United Kingdom.
Lot / Code Information
Serial No. (Exp Date): 35283 (01/22/2017), 35339 (01/22/2017), 35354 (01/22/2017), 35355 (01/22/2017), 35458 (01/22/2017), 35474 (01/22/2017), 35487 (01/22/2017), 35492 (01/22/2017), 35561 (01/22/2017), 35565 (01/22/2017), 35568 (01/22/2017), 35603 (01/22/2017), 35614 (02/05/2017), 35615 (02/05/2017), 35617 (02/05/2017), 35618 (02/05/2017), 35624 (02/05/2017), 35625 (02/05/2017), 35634 (02/05/2017), 35705 (02/05/2017), 35706 (02/05/2017), 35767 (02/05/2017), 35771 (02/05/2017), 35774 (02/05/2017), 35795 (02/05/2017), 35797 (02/05/2017), 35801 (02/05/2017), 35807 (02/05/2017), 35826 (02/05/2017), 35856 (02/05/2017), 35857 (02/05/2017), 35862 (02/05/2017), 35864 (02/05/2017), 35887 (02/05/2017), 35888 (02/05/2017), 35890 (02/05/2017), 35891 (02/05/2017), 35900 (02/05/2017), 35904 (02/05/2017), 35905 (02/05/2017), 35906 (02/05/2017), 35908 (02/05/2017), 35909 (02/05/2017), 35910 (02/05/2017), 35911 (02/05/2017), 35913 (02/05/2017), 35914 (02/05/2017), 35915 (02/05/2017), 35926 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(05/01/2017), 39734 (05/01/2017)
Other Recalls from Cyberonics, Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0555-2018 | Class II | VNS(R) Therapy Programmer, GMDN: 44077, Model ... | Dec 2, 2017 |
| Z-2255-2018 | Class II | VNS Therapy Programmer, Model 3000, v1.0 System | Nov 13, 2017 |
| Z-3020-2017 | Class II | VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ ... | Jun 13, 2017 |
| Z-0659-2016 | Class II | VNS Therapy AspireSR Generator Model 106. In... | Dec 18, 2015 |
| Z-0645-2016 | Class II | Cyberonics Vagus Nerve Stimulator VNS Therapy A... | Nov 18, 2015 |
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.