Cyberonics VNS Therapy Generator Recalled for Incorrect Serial Number Labeling
Cyberonics is recalling one VNS Therapy AspireHC Model 105 Generator distributed in Pennsylvania due to an incorrect serial number on the device label.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation and labeling issue (incorrect serial number) with no reported injuries, illnesses, or functional defects.
Plain-English summary
Cyberonics, Inc. is recalling one unit of the Cyberonics VNS Therapy AspireHC, Model 105 Generator. The device is an implantable system indicated for use as an adjunctive therapy in reducing the frequency of seizures.
The recall was initiated because the specific unit was distributed with an incorrect serial number printed on the device's label. The affected device has Serial Number 31309 and was distributed to Pennsylvania.
Consumers and healthcare providers with this specific device should contact Cyberonics, Inc. for further instructions on how to proceed.
The recalled product
- 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…
- Manufacturer
- Cyberonics, Inc
- Hazard
- Affected units
- 1
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial Number: 31309
- UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.
Distribution
Distributed in 1 state:
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