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VNS Therapy Aspire HC Generator and VNS, Model 105 recallZ-0210-2012 · Cyberonics, Inc · initiated Aug 12, 2011

Terminated All recalls posted in November 2011

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cyberonics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Cyberonics sent a Field Safety Alert on August 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm decided to recall and initiated contact with implanting facilities in the United States on 08/15/2011. A Field Safety Alert was delivered on 09/19/2011 to implanting facilities. Customers were instructed not to prescribe AspireHC pulse generators for implant until Cyberonics resumes shipment of AspireHC pulse generators that have the issue remedied. Cyberonics recommends that physicians continue their current practice of titrating programming parameters for patients implanted with an AspireHC pulse generator to achieve appropriate clinical outcomes, paying particular attention to report of: Lack or loss of efficacy Pain, inflammation, swelling/edema in the neck area; and/or Patient perception of stimulation or muscle twitching in the area surrounding the implant. Cyberonics recommended routine systems diagnostic testing to aid in device and patient monitoring. Physicians may contact Clinical Technical Support at 866-882-8804 or via email at [email protected]. For questions regarding this recall call 281-228-7323.

Recall details

Recall number
Z-0210-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 12, 2011
Posted by the FDA
Nov 18, 2011
Recalling firm
Cyberonics, Inc
Quantity
340 units
Product code
LYJ
FDA submissions
P970003
Distribution
Worldwide Distribution - USA including TN, TX, IL, OH, FL, CA, CO, OR, AZ, NY, PA, MO, NJ, WI, OK, MI, ID, KY, IA, MA, NE, GA, LA, NY, and Norway.

Product description

VNS Therapy Aspire HC Generator and VNS, Model 105 Cyberonics, Inc. 100 Cyberonics Blvd., Houston, TX 77058 For implantation in humans to treat Epilepsy and Depression.

Code information (models, lots, serial numbers)

Model 105, VNS Therapy AspireHC Generator

Other devices under the same FDA submission

23 devices cleared under P970003 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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