FDA Medical Device Recalls (openFDA)
ela Medical Llc: Alto implantable cardioverter defibrillator
- Recall number
- Z-0176-05
- Recalling firm
- ela Medical Llc
- Product
- Alto implantable cardioverter defibrillator
- Status
- Terminated
- Initiated
- 2004-10-21
- Posted
- 2004-11-04
- Terminated
- 2005-11-14
- 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 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, serial or model codes
- Model Numbers DR model 614, VR model 615
- 510(k) numbers
- not on file
- PMA numbers
- ["P980049/S3","P980049/S6"]
- Product code
- LWS
- Firm FEI
- 2182863
- Firm city
- Plymouth
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28