Atlas VR, Models V-199
FDA device recall Z-0149-06 · posted 2005-11-16 · Terminated
Recall details
- Recalling firm
- St Jude Medical
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 13097
- Distribution
- 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
- Date initiated
- 2005-10-06
- Date posted
- 2005-11-16
- Date terminated
- 2012-02-10
- Location
- Sylmar, CA
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