Baha 90430Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09321502012898), received between Oct 24, 2017 and Dec 31, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 31, 2025Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOOSE ABUTMENT, SORENESS, INFECTION, BALANCE ISSUES, HEADACHE, TINNITUS, AND SKIN OVERGROWTH. THE PATIENT WAS SUBSEQUENTLY TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

  Patient problems: Balance Problems; Headache; Impaired Healing; Skin Infection; Tinnitus

  MAUDE report 23931791 ↗
• InjuryDec 31, 2025Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Detachment of Device or Device Component; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT EXPERIENCED A LOOSE ABUTMENT, SORENESS, INFECTION, BALANCE ISSUES, HEADACHE, TINNITUS, AND SKIN OVERGROWTH. THE PATIENT WAS SUBSEQUENTLY TREATED WITH TOPICAL ANTIBIOTICS (SPECIFIC DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

  Patient problems: Balance Problems; Headache; Impaired Healing; Skin Infection; Tinnitus

  MAUDE report 23931782 ↗
• InjuryDec 8, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PER THE CLINIC, THE PATIENT DEVELOPED GRANULATION AT THE IMPLANT SITE. THE PATIENT THEN UNDERWENT REVISION SURGERY UNDER GENERAL ANAESTHETIC ON (B)(6) 2021, IN ORDER TO HAVE A MAGNET PLACED ON THE INTERNAL FIXTURE, CONVERTING THE PATIENT TO A SUBCUTANEOUS BAHA IMPLANT SYSTEM. NO OTHER EVENT OR COMPLICATIONS THAT MAY HAVE CONTRIBUTED TO THE DECISION TO CONVERT THE PATIENT WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12965817 ↗
• InjuryOct 24, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PER THE CLINIC, THE PATIENT EXPERIENCED IRRITATION AND INFLAMMATION AT THE IMPLANT SITE AND SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2017.

  Patient problems: Inflammation

  MAUDE report 6975430 ↗