MED-EL recalls SONATATIi100 cochlear implants with helium leak test results outside specifications. These implants 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 SONATATIi100 cochlear implants that failed helium leak tests. This could mean the implants don't meet safety standards for hearing-impaired users.
The implants were distributed even though helium leak tests showed results outside the required safety standards. This could mean the implants are not safe for hearing-impaired users.
People with hearing impairments who use the SONATATIi100 cochlear implant system are affected. Those with the specific serial numbers listed are most at risk.
Check if your implant is one of the SONATATIi100 types: FLEXsoft, H Standard, or Standard. Look for the specific serial numbers listed in the recall notice.
Identify if your implant is a SONATATIi100 FLEXsoft, H Standard, or Standard type.
The implants were distributed despite helium leak test results not meeting cochlear implant safety standards.
SONATATIi100 FLEXsoft, H Standard, and Standard types with specific serial numbers listed in the recall notice.
The recall does not specify a stop-use instruction; check the serial numbers to see if your implant is affected.
We’ve drafted a message you can send MED-EL to request your refund or repair — edit it as you like.
Subject: Recall Z-2137-2019 — MED-EL MED-EL Hello, I own a MED-EL that is covered by recall Z-2137-2019 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.
