Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR recall
Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
Why was Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR recalled?
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers 36602, 37019, 39097, 40311, 40465
- Product
- Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
- Recalling firm
- Cyberonics, Inc
- Quantity
- 29 units
- Distribution
- US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.
- Recall date
- January 27, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)