Recall Z-0858-2015— Cyberonics, Inc
Class II · Terminated
Class II FDA medical device recall by Cyberonics, Inc, initiated 2014-11-20, terminated 2016-02-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The recalled product was distributed with an incorrect serial number printed on the device's label..
- Recalling firm
- Cyberonics, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-11-20
- Terminated
- 2016-02-08
- Firm location
- Houston, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.