BCI Bone Conduction Implant Kit 52180Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09008738521805), received between Feb 6, 2020 and Apr 22, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “No Device Output” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026No Device Output

  THE USERS HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24950856 ↗
• MalfunctionMar 12, 2024No Device Output; No Device Output

  THE USER HIT SIDE OF HIS HEAD WITH IMPLANT VERY HARD AND AFTERWARDS THE DEVICE WAS NO LONGER FUNCTIONING.

  Patient problems: Failure of Implant

  MAUDE report 18885538 ↗
• MalfunctionOct 30, 2023No Device Output; No Device Output

  THE USER SUDDENLY LOST HEARING SENSATION IN EARLY SUMMER OF 2023.

  Patient problems: Failure of Implant

  MAUDE report 18028867 ↗
• MalfunctionOct 27, 2023No Device Output; No Device Output

  NO HEARING PERFORMANE WITH THE DEVICE WAS REPORTED. REIMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18019590 ↗
• MalfunctionMay 24, 2022No Device Output; Output Problem; No Device Output; Output Problem

  THE USER CAME IN TO UPGRADE THE AUDIO PROCESSOR (AP) AFTER HIS PREVIOUS AP BROKE. THE USER HAS NOT BEEN ABLE TO HEAR ANY SOUND SINCE THAT TIME.

  Patient problems: Failure of Implant

  MAUDE report 14485973 ↗
• InjuryJul 2, 2021Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER REPORTED A SHOCKING SENSATION AROUND THE IMPLANT SITE WHICH ALSO EXTENDS TO HER RIGHT EAR AND CHEEK. SHE REPORTS THIS SENSATION WITH THE AUDIO PROCESSOR (AP) IN PLACE AND ALSO WHEN NOT WEARING THE AP. RE-IMPLANTATION TOOK PLACE ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12105886 ↗
• InjuryJul 2, 2021Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER REPORTED A SHOCKING SENSATION AROUND THE IMPLANT SITE WHICH ALSO EXTENDS TO HER RIGHT EAR AND CHEEK. SHE REPORTS THIS SENSATION WITH THE AUDIO PROCESSOR (AP) IN PLACE AND ALSO WHEN NOT WEARING THE AP. RE-IMPLANTATION TOOK PLACE ON (B)(6) 2021. THIS REPORT REFERS TO 9710014-2021-00473. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 12105884 ↗
• InjuryMar 30, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE AUDIOLOGIST REPORTED THAT SOME PART OF THE IMPLANT IS STICKING OUT AND POKING UP THE SKIN. THE USER ALSO REPORTS A SOUND LIKE 'PEBBLES IN A TIN CAN' RATTLING WHICH THE AUDIOLOGIST STILL HAS NOT BEEN ABLE TO RESOLVE, THIS NOISE WAS FIRST REPORTED ON (B)(6) 2020. IT WAS FURTHER REPORTED THAT DURING IMPLANTATION THE SURGEON USED HIS OWN SCREWS TO FIXATE THE DEVICE. HE USED 8MM STRYKER SELF-DRILLING / SELF-LOCKING SCREWS. THIS WAS PARTIALLY DUE TO THE HOSPITAL NOT ACCEPTING OR STERILIZING ANY OF OUR REUSABLE INSTRUMENTATION, WHICH WAS UNKNOWN UNTIL AFTER THE CASE STARTED. THE USER WAS EXPLANTED ON (B)(6) 2021. THIS REPORT REFERS TO 9710014-2020-00087. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 11587124 ↗
• InjuryFeb 6, 2020Improper or Incorrect Procedure or Method; Output Problem; Improper or Incorrect Procedure or Method; Output Problem

  THE AUDIOLOGIST REPORTED THAT THE INITIAL ACTIVATION WENT FINE BUT SOME PART OF THE IMPLANT IS STICKING OUT AND POKING UP THE SKIN. THE USER ALSO REPORTS A SOUND LIKE 'PEBBLES IN A TIN CAN' RATTLING WHICH THE AUDIOLOGIST STILL HAS NOT BEEN ABLE TO RESOLVE, THIS NOISE WAS FIRST REPORTED ON (B)(6) 2020. THE AUDIOLOGIST FEELS THE IMPLANT MAY NOT BEEN FIXED WELL. THE SURGEON HAS ORDERED A CT SCAN AND THE AUDIOLOGIST IS AWAITING HIS FEEDBACK.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9676170 ↗