Reported Aug 23, 2017 · Terminated
VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 105. Product Usage: United States…
Cyberonics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cyberonics, Inc · 100 Cyberonics Blvd · Houston, TX · 77058-2069
Is this the product you have?
3 of 3 products
| Model / number | Product as published |
|---|---|
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. |
- Lot codes and dates
- Serial No. (Exp
- Date)
400 of 400 codes
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 (02/05/2017)36060 (05/01/2017)36067 (02/05/2017)36068 (02/05/2017)36073 (02/05/2017)36082 (02/05/2017)36084 (02/05/2017)36085 (02/05/2017)36090 (02/05/2017)36132 (02/05/2017)36140 (02/05/2017)36141 (02/05/2017)
- Amount recalled
- 396 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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