ela Medical Llc Alto implantable cardioverter defibrillator Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alto implantable cardioverter defibrillator
Brand
ela Medical Llc
Lot Codes / Batch Numbers
Model Numbers DR model 614, VR model 615
Products Sold
Model Numbers DR model 614, VR model 615
ela Medical Llc is recalling Alto implantable cardioverter defibrillator due to Alto Implantable Defibrillators Models 614 and 615. These models can experience sudden no output, and early end of life characteristics due to metal . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026