FDA Recall
Terminated
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.
Recall: Z-0858-2015
·
Initiated November 20, 2014
Recall
- Recall Number
- Z-0858-2015
- Event Number
- 69844
- Firm
- Cyberonics, Inc
- FEI Number
- 1000117004
- Product Code
- LYJ
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- November 20, 2014
- Posted
- December 23, 2014
- Terminated
- February 8, 2016
- Address
- 100 Cyberonics Blvd, Houston, TX, 77058-2069
Description
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.
Reason
The recalled product was distributed with an incorrect serial number printed on the device's label.
Action
The recalling firm visited the one consignee on 11/4/2014 to inform the consignee of the recall and arrange for the return of the recalled devices.
Distribution
Distributed to PA.
Quantity
1 unit