MED-EL recalls specific cochlear implant models due to helium leak test failures in production. Affected units may not meet safety standards for hearing-impaired users.
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
MED-EL is recalling certain cochlear implant systems that failed helium leak tests during manufacturing. This could mean the implants don't meet safety standards for hearing-impaired users.
The implants were distributed even though helium leak tests did not meet safety standards. This could lead to improper function or potential safety issues for users who rely on these devices for hearing.
People with hearing impairments who use the recalled cochlear implant models are affected. Those with the specific implant types listed in the recall are most at risk.
Check if your implant has the model names listed: Mil000 CONCERTO PIN +FLEX28, Mi1000 CONCERTO +FLEX28, or other variants with specific serial numbers provided in the recall.
Identify if your implant matches the specific models listed in the recall notice, including the serial numbers provided.
The recall is happening because the implants were distributed despite failing helium leak tests, which means they do not meet cochlear implant safety standards.
The recall does not specify a remedy, so you should check with MED-EL directly to determine next steps.
Yes, the affected models include Mil000 CONCERTO PIN +FLEX28, Mi1000 CONCERTO +FLEX28, and other variants with specific serial numbers listed in the recall.
We’ve drafted a message you can send MED-EL to request your refund or repair — edit it as you like.
Subject: Recall Z-2136-2019 — MED-EL MED-EL Hello, I own a MED-EL that is covered by recall Z-2136-2019 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.
