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Terminated

Alto implantable cardioverter defibrillator

FDA Recall Z-0176-05 · Posted 2004-11-04

Recalling Firmela Medical Llc
Recall StatusTerminated
Product CodeLWS
Date Initiated2004-10-21
Date Terminated2005-11-14
Product Quantity434 users recived the product

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.

Firm 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.

Root Cause

Other

Distribution Pattern

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 the subject of the correction. It should be noted that in many cases, the physician following the patient is not the physician who implanted the device. Because ELA is requesting assistance to monitor the performance of implanted devices, this notification is directed at the physicians who are following the patients.

Official Source

View FDA Recall →

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

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