Mi1000 MED-EL CONCERT +FLEX24 06274Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 09008737062743), received between Sep 18, 2018 and Nov 3, 2025 — classified as 14 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (12 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING CHOLESTEATOMA REMOVAL SURGERY, THE DOCTOR DECIDED LAST MINUTE TO EXPLANT THE DEVICE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23449272 ↗
• InjuryAug 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE HAS BEEN REMOVED DUE TO INFLAMMATION.

  Patient problems: Inflammation

  MAUDE report 22748346 ↗
• MalfunctionJun 26, 2025Impedance Problem; Impedance Problem

  THE USER NOTICED IN THE LAST 2 MONTHS THAT WHEN HE PRESSES WITH HIS FINGER IN THE MASTOIDECTOMY REGION, THE IMPLANT SOUND BECOMES LOUDER AND CLEARER AND HE CAN HEAR BETTER. AS SOON AS HE STOPS PRESSING, THE SOUND DEGRADES. THE USER HAS BEEN REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334660 ↗
• MalfunctionMay 22, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE USER IS A LONG-TIME NON-USER WHO RECEIVED AN UPGRADE THAT THEY WERE ATTEMPTING TO ACTIVATE. IT IS UNCLEAR HOW LONG IT HAS BEEN SINCE HE HAS NOT HEARD WITH HIS IMPLANT. AT HIS LAST VISIT, THE USER HAD SAID 6 MONTHS. AT THIS VISIT, HE SAID 2-3 YEARS. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22068291 ↗
• InjuryApr 30, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER HAS EXPERIENCED REPEATED INFECTIONS STARTING IN (B)(6) 2022. THE USER HAS BEEN EXPLANTED.

  Patient problems: Tissue Breakdown

  MAUDE report 21932663 ↗
• MalfunctionApr 2, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750917 ↗
• MalfunctionNov 15, 2024Impedance Problem; Impedance Problem

  THE USERS HEARING SENSATIONS STARTED TO GET WORSE AT THE BEGINNING OF (B)(6) 2024.

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

  MAUDE report 20692835 ↗
• MalfunctionOct 15, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 20451066 ↗
• MalfunctionOct 7, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. REPORTEDLY, THE CHILD HAD BEEN HIT ON THE HEAD WITH A STICK. RE-IMPLANTATION IS CONSIDERED, BUT NOT SCHEDULED YET.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 20382552 ↗
• MalfunctionMay 17, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER HAS BEEN EXPLANTED AS HE HAD NO HEARING SENSATION WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 19339397 ↗
• MalfunctionApr 11, 2024Impedance Problem; Impedance Problem

  IN (B)(6) 2023, A DECLINE IN HEARING PERFORMANCE SPECIFICALLY WITH THE RIGHT IMPLANT WAS OBSERVED BY THE USER. THE USER HAS BEEN RE-IMPLANTED ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 19085786 ↗
• InjuryDec 18, 2023Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  WHEN THE USER WAS SEEN A FEW WEEKS AGO ((B)(6) 2023), IT WAS NOTED THAT THE TYMPANIC MEMBRANES ON BOTH SIDES ARE RETRACTED AND ON THE RIGHT SIDE THE TYMPANIC MEMBRANE IS ADHERENT TO THE ELECTRODE ARRAY AT THE FOSSA INCUDI. AN EXTRUSION OF THE ELECTRODE ARRAY CAN'T BE EXCLUDED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Tears

  MAUDE report 18345219 ↗
• MalfunctionNov 2, 2023Impedance Problem; Impedance Problem

  THE USER REPORTED THAT THE SOUND HAD DECREASED DRAMATICALLY SINCE HE HIT HIS HEAD A FEW DAYS PRIOR (B)(6) 2023. REIMPLANTATION HAS BEEN SUGGESTED.

  Patient problems: Failure of Implant

  MAUDE report 18056245 ↗
• MalfunctionMay 17, 2023Impedance Problem; Impedance Problem

  THE HEARING PERFORMANCE WITH THE DEVICE WAS REPORTEDLY AFFECTED. ACCORDING TO PARENTS OF THE USER THERE WAS AN ACCIDENT IN OCTOBER 2021 WHEN THE USER FELL IN THE BATHROOM AND TORE THE BACK OF HIS EAR. THE USER WAS RE-IMPLANTED ON (B)(6)2022.

  Patient problems: Failure of Implant

  MAUDE report 16944042 ↗
• MalfunctionDec 19, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER COMPLAINS ABOUT WORSENING OF SOUND PERCEPTION WITH THE DEVICE IN THE LAST TWO MONTHS (APPROXIMATELY OCTOBER 2022). RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 16002770 ↗
• MalfunctionAug 1, 2022Output Problem; Output Problem

  THE USER FELL AND HE COULD NOT HEAR ANYMORE WITH THE DEVICE. THE USER WAS RE-IMPLANTED WITH A NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 15137320 ↗
• InjuryMar 9, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER HAS BEEN EXPLANTED DUE TO SEVERE INFECTION. THE INFECTION STARTED IN MID-(B)(6) 2021.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 13710739 ↗
• MalfunctionSep 27, 2021Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  THE DEVICE WAS EXPLANTED ON (B)(6) 2021 BECAUSE THE RECIPIENT HAD SUDDENLY LOST AUDITORY SENSATION WITH THE DEVICE 3 MONTHS PRIOR (JULY 2021). THE USER HAS BEEN REIMPLANTED WITH A NEW DEVICE WHICH IS BEING USED WITHOUT ANY PROBLEMS.

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

  MAUDE report 12533377 ↗
• MalfunctionJul 27, 2021Output Problem; Output Problem

  REPORTEDLY, THE RECIPIENT WAS HIT OVER THE IMPLANT SIDE WITH A STONE ON (B)(6) 2021. ON (B)(6)2021 THE RECIPIENT WAS CHECKED, AND THE MOTHER REPORTED THAT HE COULD NO LONGER HEAR USING THE DEVICE. RE-IMPLANTATION IS CONSIDERED. HOWEVER, NO DATE HAS BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 12231962 ↗
• InjuryJul 6, 2021Migration; Migration

  THE USER UNDERWENT A REVISION SURGERY ON (B)(6) 2021 TO TRY A RE-INSERTION OF THE ELECTRODE ARRAY WHICH MIGRATED OUT FROM THE COCHLEA. THE FULL ACTIVE ELECTRODE ARRAY MIGRATED. BASED ON INTRA-OPERATIVE MEASUREMENTS IT WAS DECIDED TO REIMPLANT WITH A NEW DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 12120320 ↗
• MalfunctionOct 23, 2020Migration; Migration

  INITIALLY AFFECTED CHANNELS WERE OBSERVED DURING IN SITU TESTING. RECIPIENT REPORTED HEARING 'MUFFLED' SOUND. PROGRAMMING CHANGES WERE MADE TO ACCOMMODATE THE AFFECTED CHANNELS. RECIPIENT'S HEARING PERFORMANCE AFTER PROGRAMMING WAS REPORTEDLY GOOD. OBJECTIVE SPEECH TESTING SCORES WERE APPROXIMATELY 80%, CONSISTENT WITH PREVIOUS TEST RESULTS AND IT WAS DECIDED AT THAT TIME THAT THE RECIPIENT WILL BE FURTHER MONITORED. AS PER ADDITIONAL INFORMATION RECEIVED IN OCTOBER 2020 THE RECIPIENT REQUESTED A REVISION SURGERY DUE TO DECREASE IN HEARING PERFORMANCE. THE SCHEDULED SURGERY WAS CANCELLED DUE TO INSURANCE REASON. NO NEW DATE FOR RE-IMPLANTATION HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 10724664 ↗
• InjuryAug 12, 2020Circuit Failure; Output Problem; Circuit Failure; Output Problem

  THE RECIPIENT'S HEARING PERFORMANCE USING THE DEVICE WAS AFFECTED. THE RECIPIENT HAS BEEN RE-IMPLANTED ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10395629 ↗
• MalfunctionApr 29, 2020Output Problem; Output Problem

  THE USER FELL AND HIT HER HEAD DIRECTLY AT THE IMPLANT SITE AND THE AUDIO PROCESSOR BROKE. THE AUDIO PROCESSOR WAS REPLACED TWICE, HOWEVER THOSE ATTEMPTS DID NOT SOLVE THE PROBLEM AND THE USER STILL DID NOT HAVE ACCESS TO SOUND.

  Patient problems: Failure of Implant

  MAUDE report 10008624 ↗
• InjuryMar 3, 2020Output Problem; Output Problem

  RECIPIENT STARTED TO SPEAK LOUDER THAN BEFORE. HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. NO INCIDENT OF A TRAUMA OR ACCIDENT WAS REPORTED BY THE PARENTS.THE RECIPIENT WAS RE-IMPLANTED ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 9779583 ↗
• InjuryFeb 25, 2020Output Problem; Output Problem

  THE USER WAS SEEN ON (B)(6) 2020 FOR FOLLOW-UP MAPPING AND IN SITU TESTING REVEALED AFFECTED CHANNELS. THE USER_S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. ALTHOUGH PERFORMANCE IS DIFFICULT TO ASSESS AS THE USER IS VERY YOUNG.

  Patient problems: Failure of Implant

  MAUDE report 9749521 ↗

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-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-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-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