FDAFDA · Food and drugs·Recall number Z-0858-2015
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.
Published December 31, 2014 · Recall initiated: November 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The recalled product was distributed with an incorrect serial number printed on the device's label.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Cyberonics, Inc
- Distributor
- Distributed to PA.
- Lot
- Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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