Recall Z-0858-2015
Cyberonics, Inc · initiated November 20, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
Reason for recall
The recalled product was distributed with an incorrect serial number printed on the device's label.
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-0858-2015
- Initiated
- November 20, 2014
- Posted by FDA
- December 23, 2014
- Terminated
- February 8, 2016
- Product code
- LYJ – Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Quantity
- 1 unit
- Distribution
- Distributed to PA.
- Recalling firm
- Cyberonics, Inc, Houston, TX