Alto implantable cardioverter defibrillator
- Company
- Ela Medical Llc
- Recall Initiated
- October 21, 2004
- Posted
- November 4, 2004
- Terminated
- November 14, 2005
- Recall Number
- Z-0176-05
- Quantity
- 434 users recived the product
- Firm Location
- Plymouth, MN
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.
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 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.
Lot / Code Info
Model Numbers DR model 614, VR model 615
Root Cause
Other
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.