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Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists ...

FDA Recall #Z-0858-2015 — Class II — November 20, 2014

Recall #Z-0858-2015 Date: November 20, 2014 Classification: Class II Status: Terminated

Product Description

Cyberonics VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Reason for Recall

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

Recalling Firm

Cyberonics, Inc — Houston, TX

Classification

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

Product Type

Devices

Product Quantity

1 unit

Distribution

Distributed to PA.

Code Information

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

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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