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Terminated

Cyberonics VNS Therapy Bipolar Lead, Model #302; Sterile, Single use only; Distributed by Cyberonics, Inc., Houston, TX 77058.

FDA Recall Z-0172-2008 · Posted 2007-11-28

Recalling FirmCyberonics, Inc
Recall StatusTerminated
Product CodeLYJ
Date Initiated2007-08-02
Date Terminated2009-10-05
Product Quantity34,719 units.

Reason for Recall

Dissolution/Fractures to the leads of the VNS Therapy System

Firm Action

Cyberonics issued a correction notice (Safety Alert) to physicians in June of 2007, informing them of the present labeling and including updated labeling to provide instructions on how to detect lead fractures and how to minimize risk to patients.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA and countries of Argentina, Australia, Austria, Belgium, Canada, Costa Rica, Cyprus, Czech Rep, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Malta, Mexico, Netherlands, Northern Ireland, Norway, Poland, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom, and Venezuela.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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