MED-EL recalls PULSARci100 cochlear implants due to helium leak test results not meeting safety standards. Affected units may have safety risks requiring immediate attention.
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
MED-EL is recalling its PULSARci100 cochlear implant system because some units failed helium leak tests, which could pose safety risks. This affects individuals who use cochlear implants for severe hearing loss. The recall is important because improper helium testing might lead to device failure or injury.
The hazard involves cochlear implants that were distributed without passing helium leak tests. Helium leaks in medical implants can compromise device safety, potentially causing malfunctions or injury if the implant fails under normal use conditions.
People with severe to profound hearing loss who use MED-EL cochlear implants are most at risk. The recall specifically targets units with serial number 202001.
Check for the serial number 202001 on the implant. The PULSARci100 is a cochlear implant system used for severe to profound hearing loss.
Look for the serial number 202001 on the implant to confirm if it is affected.
The recall is due to helium leak test results not meeting cochlear implant safety standards.
Check the serial number on the implant; if it is 202001, contact MED-EL for guidance.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send MED-EL to request your refund or repair — edit it as you like.
Subject: Recall Z-2138-2019 — MED-EL MED-EL Hello, I own a MED-EL that is covered by recall Z-2138-2019 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.
