Mi1000 MED-EL CONCERT PIN +STANDARD 06267Recalls & reported problems

Summary

The FDA's MAUDE database contains 89 adverse event reports that list this exact device (DI 09008737062675), received between Oct 9, 2017 and Sep 22, 2026 — classified as 23 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (47 reports).

4 other recalls cover devices cleared under the same FDA submission (P000025); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 89 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Impedance Problem

  The user has no more hearing sensation. In situ measurements show all channels with high impedance. Former measurements were indicative of a functional device.Re-implantation is considered.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50852080 ↗
• MalfunctionJun 3, 2026Impedance Problem

  THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25371574 ↗
• MalfunctionApr 30, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25044216 ↗
• MalfunctionApr 16, 2026Circuit Failure

  THE USER EXPERIENCED A SUDDEN LOSS OF HEARING SENSATION. RE-IMPLANTATION IS BEING CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24903375 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS EXPLANTED.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 24314572 ↗
• MalfunctionDec 17, 2025Circuit Failure; Impedance Problem; Circuit Failure; Impedance Problem

  THERE WAS A SUDDEN LOSS OF HEARING SENSATION WITH THE DEVICE. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829369 ↗
• MalfunctionDec 10, 2025Impedance Problem; Impedance Problem

  IN SITU TESTING SHOWS AFFECTED CHANNELS. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23766900 ↗
• MalfunctionAug 8, 2025Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748345 ↗
• MalfunctionJul 23, 2025Impedance Problem; Impedance Problem

  THE USER REPORTED REDUCED CLARITY IN MAY 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574405 ↗
• MalfunctionJun 26, 2025Impedance Problem; Impedance Problem

  THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334655 ↗
• MalfunctionJun 12, 2025Impedance Problem; Impedance Problem

  THE USER HAS NO REACTION TO SOUND WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22192158 ↗
• MalfunctionJun 3, 2025Impedance Problem; Impedance Problem

  THE USER HAS A SUDDEN LOSS OF HEARING SENSATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130057 ↗
• MalfunctionMay 7, 2025Impedance Problem; Impedance Problem

  THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974510 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER WAS ADMITTED TO THE EMERGENCY ROOM DUE TO AN EAR INFECTION. THE EAR DRUM WAS PERFORATED DUE TO THE INFECTION. THE USER WAS EXPLANTED DUE TO THE DEGREE OF INFECTION FOUND.

  Patient problems: Ear infection

  MAUDE report 21718384 ↗
• MalfunctionMar 18, 2025Impedance Problem; Impedance Problem

  SUDDEN LOSS OF HEARING SENSATION. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 21631620 ↗
• MalfunctionMar 13, 2025Impedance Problem; Impedance Problem

  SUDDEN LOSS IN HEARING PERFORMANCE WITH THE DEVICE. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 21593774 ↗
• MalfunctionFeb 24, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS CONSIDERED BUT THIS WILL LIKELY TAKE PLACE IN 2-3 MONTHS AT THE EARLIEST.

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

  MAUDE report 21444803 ↗
• MalfunctionFeb 12, 2025Circuit Failure; Circuit Failure

  THE USER HAS NO HEARING SENSATION WITH THE DEVICE. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 21362779 ↗
• MalfunctionJan 9, 2025Impedance Problem; Impedance Problem

  THE USER HAS BEEN RE-IMPLANTED. THERE IS NO OTHER INFORMATION AVAILABLE. THIS IS A COMBINED INITIAL AND FINAL REPORT.

  Patient problems: Failure of Implant

  MAUDE report 21110091 ↗
• MalfunctionDec 18, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER COMPLAINED ABOUT PAIN AT THE IMPLANT SITE AFTER BEING HIT BY A BALL IN THAT AREA. AN APPOINTMENT WILL BE ARRANGED FOR THE USER.

  Patient problems: Implant Pain

  MAUDE report 20961146 ↗
• MalfunctionDec 11, 2024Circuit Failure; Circuit Failure

  THE USER WAS UNSURE IF SHE HAD EXPERIENCED A HEAD TRAUMA WHILE PAINTING HER HOUSE, BUT SHE NOTED THAT HER RONDO 3 STOPPED WORKING. THE USER WAS RE-IMPLANTED.

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

  MAUDE report 20900515 ↗
• MalfunctionNov 7, 2024Impedance Problem; Impedance Problem

  A SUDDEN LOSS OF HEARING PERCEPTION WITH THE DEVICE IS REPORTED. THE USER WAS REIMPLANTED.

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

  MAUDE report 20628995 ↗
• MalfunctionAug 1, 2024Impedance Problem; Impedance Problem

  THE USER REPORTED A SUDDEN DECREASE IN HEARING PERFORMANCE WITH THE DEVICE. IN SITU MEASUREMENTS FROM (B)(6) 2024 SHOWED 4 CHANNELS WITH HIGH IMPEDANCE AND 3 CHANNELS INVOLVED IN SHORT CIRCUITS.

  Patient problems: Failure of Implant

  MAUDE report 19880521 ↗
• MalfunctionJul 18, 2024Circuit Failure; Insufficient Device Problem Information; Circuit Failure; Insufficient Device Problem Information

  ON (B)(6) 2024, THERE WAS A SUDDEN, UNCOMFORTABLE, PAINFUL SENSATION IN THE IMPLANT AREA WHEN THE AUDIO PROCESSOR WAS WORN. RE-IMPLANTATION IS CONSIDERED, THE DATE HAS NOT BEEN SCHEDULED YET.

  Patient problems: Failure of Implant; Implant Pain

  MAUDE report 19773704 ↗
• MalfunctionJun 27, 2024Impedance Problem; Impedance Problem

  AROUND (B)(6) 2024 THE USER SUDDENLY STOPPED RESPONDING TO SOUNDS. THE USER WILL BE REIMPLANTED WHEN THE CLINIC RECEIVES A NEW DEVICE.

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

  MAUDE report 19622517 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000025. One submission often covers many models, so check the product and lot details in each record.

• Z-2356-2024 · Apr 18, 2024 · Open, Classified
  Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
• Z-2136-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi100
• Z-2138-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an implantable part of the MED EL Cochlear Implant System and can only be used toge
• Z-2137-2019 · Oct 16, 2018 · Terminated
  MED EL Cochlear Implant System, SONATATIi100, sold under the following implant types: a. SONATAti100 FLEXsoft; b. SONATAti100 H Standard; c. SONATAti100 Standard