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Terminated

Photo DR, Model V-230HV Implantable Cardioverter Defibrillator

FDA Recall Z-0146-06 · Posted 2005-11-16

Recalling FirmSt Jude Medical
Recall StatusTerminated
Product CodeLWS
Date Initiated2005-10-06
Date Terminated2012-02-10
Product Quantity5323

Reason for Recall

Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support.

Firm Action

Notification material sent to physicians by FedEx. Acknowledgement of receipt of the notification material will be monitored with this information being fed back to St. Jude Medical CRMD in Sylmar, California. In addition, St Jude Medical issued a press release on October 7, 2005.

Root Cause

Other

Distribution Pattern

Nationwide and Western Europe: Austria Belgium Denmark Finland France Germany Italy Netherlands Poland Portugal Spain Sweden UK Switzerland Greece Malta Eastern Europe: Czech Republic Lithuania Latvia Romania Bulgaria Croatia Slovenia Slovakia Russia Serbia Middle East! Africa: South Africa Israel Iran Iraq Jordan Lebanon Suadi Arabia Turkey Latin America: Argentina Brazil Chile Colombia EI Salvador Guatamala Mexico Uruguay Venezuela Asia-Pacific: China Hong Kong Malaysia Taiwan Thailand Australia-New Zealand: Australia New Zealand and Canada

Official Source

View FDA Recall →

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

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