Advanced Bionics recalls HiRes 90K Advantage CI HiFocus MS Electrode cochlear implants due to missing bio-compatible materials in Japan's PMDA submission. Not distributed in the US.
Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
Advanced Bionics is recalling its HiRes 90K Advantage CI HiFocus MS Electrode cochlear implants because three materials were mistakenly left off the list of bio-compatible materials in their Japan submission. This recall does not affect US-distributed units.
The recall involves three materials that were mistakenly omitted from the list of bio-compatible materials in the firm's submission to Japan's Pharmaceuticals and Medical Devices Agency (PMDA). This could potentially cause issues if the materials are not compatible with the body, but the risk is not clearly defined in the recall notice.
People with the HiRes 90K Advantage CI HiFocus MS Electrode cochlear implant in the US are not affected by this recall since the product was not distributed there. Those who own the implant outside the US may need to check their specific model.
Check for the model 'HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04' on the implant. The product was not distributed within the US, so US users are not affected.
Verify the model number on your implant to confirm if it matches 'HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04'.
No, the product was not distributed within the US, so US customers are not affected by this recall.
Three materials used in the implant were mistakenly left off the list of bio-compatible materials in the firm's submission to Japan's PMDA.
Since the product was not distributed in the US, US customers do not need to take any action.
We’ve drafted a message you can send Advanced Bionics to request your refund or repair — edit it as you like.
Subject: Recall Z-1259-2020 — Advanced Bionics Advanced Bionics Hello, I own a Advanced Bionics that is covered by recall Z-1259-2020 from Advanced Bionics. 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
