Z-0858-2015 Class II Terminated
FDA device recall Z-0858-2015 was initiated by Cyberonics, Inc on November 20, 2014 and is designated Class II. Reason for recall: The recalled product was distributed with an incorrect serial number printed on the device's label. The recall status is terminated (terminated February 8, 2016). Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- December 31, 2014
- Initiation Date
- November 20, 2014
- Termination Date
- February 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product 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 for Recall
The recalled product was distributed with an incorrect serial number printed on the device's label.
Distribution Pattern
Distributed to PA.
Code Information
Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.