MED-EL recalls specific Mi1250 SYNCHRONY 2 cochlear implants with certain item numbers due to potential internal cracks that could cause device failure.
A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
MED-EL is recalling specific models of cochlear implants (Mi1250 SYNCHRONY 2) with item numbers 39541, 39545, and 39547. These devices may have internal cracks that could lead to non-functional implants.
A small number of these implants may have internal cracks in the electronics substrate. This could cause the device to stop working properly, but does not pose an immediate risk of injury.
Cochlear implant users with the specific item numbers listed in the recall. Those with the serial numbers provided are most at risk.
Check your device's item number (39541, 39545, or 39547) or serial numbers (859106, 860731, 860782, 863380, etc.) to see if you have a recalled model.
Review your implant's item number and serial numbers to confirm if it matches the recalled models.
No, the recall does not require immediate discontinuation. The hazard is a potential non-functional device, not an immediate safety risk.
The recall does not specify a remedy, so contact MED-EL directly for guidance on next steps.
Check your implant's item number (39541, 39545, or 39547) and serial numbers (e.g., 859106, 860731) against the provided list.
We’ve drafted a message you can send MED-EL to request your refund or repair — edit it as you like.
Subject: Recall Z-2356-2024 — MED-EL MED-EL Hello, I own a MED-EL that is covered by recall Z-2356-2024 from MED-EL. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
