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VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reduci...

FDA Recall #Z-0659-2016 — Class II — December 18, 2015

Recall #Z-0659-2016 Date: December 18, 2015 Classification: Class II Status: Terminated

Product Description

VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Reason for Recall

Recall being initiated in response to three reports of "Burst Watchdog Timeout" events occurring with the Model 106 AspireSR Generator, resulting in a device reset condition where stimulation output is disabled.

Recalling Firm

Cyberonics, Inc — Houston, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

4,935 units

Distribution

Worldwide Distribution -- United States, Austria, Belgium, Croatia, Czech Republic, Finland, France, Germany, Iceland, Italy, Netherlands, Norway, Poland, Slovakia, Spain, Sweden, Switzerland, United Kingdom, Cyprus, Israel, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, and United Arab Emirates.

Code Information

All VNS Therapy AspireSR (Model 106) Generators; Device Identifier - (01)05425025750061

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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