Z-0176-05

Alto implantable cardioverter defibrillator

Name: Z-0176-05 Alto implantable cardioverter defibrillator
Creator: ela Medical Llc
Published: 2004-10-21
License: https://open.fda.gov/license/

Ela Medical, Inc. / initiated 2004-10-21 / Terminated

FDA source

ela Medical Llc began a recall of Alto implantable cardioverter defibrillator on 2004-10-21. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0176-05
Status: Terminated
Initiated: 2004-10-21
Posted: 2004-11-04
Terminated: 2005-11-14
Recalling firm: Ela Medical, Inc.
Product: Alto implantable cardioverter defibrillator
Product code: LWS Implantable Cardioverter Defibrillator (Non-Crt)
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.
FDA 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 in commerce: 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 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.
Product codes and lots: Model Numbers DR model 614, VR model 615

Product code LWS

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)