Baha 94125Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09321502027120), received between Aug 14, 2019 and Aug 14, 2019 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K131240); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED HEARING LOSS AND INABILITY TO USE BAHA DEVICE DUE TO CHRONIC PAIN WITH DEVICE USE. IMPLANT IN SUBOPTIMAL POSITION FOR ATTRACT TYPE OF CONNECTION. AS PER PATIENT REQUEST, SURGEON PERFORMED A BAHA ATTRACT CONNECT REPLACEMENT SURGERY ON (B)(6) 2019, THE ATTRACT CONNECT HAS BEEN CHANGED TO CONNECT ABUTMENT.

  Patient problems: Hearing Impairment; Pain

  MAUDE report 8895691 ↗
• InjuryAug 14, 2019Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED HEARING LOSS AND INABILITY TO USE BAHA DEVICE DUE TO CHRONIC PAIN WITH DEVICE USE. IMPLANT IN SUBOPTIMAL POSITION FOR ATTRACT TYPE OF CONNECTION. AS PER PATIENT REQUEST, SURGEON PERFORMED A BAHA ATTRACT CONNECT REPLACEMENT SURGERY ON (B)(6) 2019, THE ATTRACT CONNECT HAS BEEN CHANGED TO CONNECT ABUTMENT.

  Patient problems: Hearing Impairment; Pain

  MAUDE report 8895620 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131240. One submission often covers many models, so check the product and lot details in each record.

• Z-1699-2014 · Apr 9, 2014 · Terminated
  Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.