Reported Dec 31, 2014 · Terminated
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS…
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 VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
- Lot codes and dates
- Serial Number31309
- UDI(01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705
- Amount recalled
- 1 unit
Where it was sold
Why it was recalled
The recalled product was distributed with an incorrect serial number printed on the device's label.
This product could cause temporary or reversible health problems — stop using it.
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