Reported Jan 27, 2016 · Terminated
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
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?
- Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
- Lot codes and dates
Serial numbers 3660237019390974031140465
- Amount recalled
- 29 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
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery 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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