Device product
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.
Z-0858-2015
Product summary
- Firm
- Cyberonics, Inc
- Event
- Event 69844
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0858-2015
Official wording
Reason: The recalled product was distributed with an incorrect serial number printed on the device's label.
Code information: Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
Distribution pattern: Distributed to PA.
Derived failure modes
-
Unknown
The recalled product was distributed with an incorrect serial number printed on the device's label.