Alto implantable cardioverter defibrillator
FDA device recall Z-0176-05 · posted 2004-11-04 · Terminated
Recall details
- Recalling firm
- ela Medical Llc
- Reason for recall
- Alto Implantable Defibrillators Models 614 and 615. These models can experience sudden no output, and early end of life characteristics due to metal migration in their controlling hybrids, causing high current drain leading to premature battery depletion.
- Action taken
- The company observed occurrences of premature battery depletion and/or prolonged charge time for some Alto 614 and Alto 615 devices. The firm is requesting physician's assistance to monitor the performance of a limited number of implanted Alto 614 and 615 devices.
- Root cause
- Other
- Status
- Terminated
- Product code
- LWS
- Quantity affected
- 434 users recived the product
- Distribution
- Nationwide. Devices were received from the manufacturer in France. After received in the US, No devices were distributed from the US to foreign consignees. 95 physicians received the recalled product.
- Date initiated
- 2004-10-21
- Date posted
- 2004-11-04
- Date terminated
- 2005-11-14
- Location
- Plymouth, MN
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