FDAClass IINovember 25, 2015

Cyberonics Vagus Nerve Stimulator recall

Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106

Why was Cyberonics Vagus Nerve Stimulator recalled?

Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit 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: 37719, 37899, 38123, 38414, 38428, 39385, 39531, 39607, 39801, 39821, 40037, 40048, 40249, 40251, 40271, 40354, 40428, 40488, 40526, 40603, 40751, 41000, 41109, 41152, 41805, 42022, 42780

Product
Cyberonics Vagus Nerve Stimulator (VNS) Therapy AspireSR Generator, Model 106
Recalling firm
Cyberonics, Inc
Quantity
27 units
Distribution
US Distribution to the states of : OR, NY, GA, PA, CA, NC, KS, FL, KY, MI, TX, IL, OH, IN, UT, CO and WV.
Recall date
November 25, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls