Recall Z-0176-05 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
ela Medical Llc
Alto implantable cardioverter defibrillator
| Date | Nov 4, 2004 (initiated Oct 21, 2004) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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. ELA Medical has contacted physicians who follow patients implanted with the devices that are th |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.