FDAClass IIDecember 31, 2014

Cyberonics VNS Therapy AspireHC recall

Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS…

Why was Cyberonics VNS Therapy AspireHC recalled?

The recalled product was distributed with an incorrect serial number printed on the device's label.

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 Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.

Product
Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS…
Recalling firm
Cyberonics, Inc
Quantity
1 unit
Distribution
Distributed to PA.
Recall date
December 31, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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