Mi1000 MED-EL CONCERT +STANDARD 06268Recalls & reported problems

Summary

The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 09008737062682), received between Jul 19, 2018 and Sep 15, 2026 — classified as 43 injuries, 69 malfunctions.

The most frequently reported specific device problem is “Output Problem” (57 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 112 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Impedance Problem

  The user's hearing performance with the device is affected.

  Patient problems: Insufficient Information

  MAUDE report 50767288 ↗
• MalfunctionAug 28, 2026Impedance Problem

  The user had a trauma right where the implant is placed. From that moment the user reported a total loss of hearing perception. The user will undergo a preventive anesthesiological consultation, and reimplantation is considered.

  Patient problems: Head Injury

  MAUDE report 50493829 ↗
• MalfunctionMar 10, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: Head Injury

  MAUDE report 24555977 ↗
• MalfunctionDec 9, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DEVICE WAS EXPLANTED ON (B)(6) 2025. "DEFECT" WAS WRITTEN AS REASON FOR EXPLANTATION; HOWEVER, IT IS ALSO INDICATED THAT THE DEVICE DID NOT CONTRIBUTE TO EXPLANTATION. ADDITIONAL INFORMATION RECEIVED STATES THAT THE USER WAS REIMPLANTED BECAUSE HEARING WITH THE DEVICE WAS NOT SATISFYING. THE USER WAS RE-IMPLANTED WITH A NEW DEVICE.

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

  MAUDE report 23755915 ↗
• MalfunctionDec 5, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. FURTHER TECHNICAL CHECKS HAVE BEEN SCHEDULED. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726038 ↗
• MalfunctionSep 25, 2025Impedance Problem; Impedance Problem

  THERE WAS A DECLINE IN HEARING WITH THE DEVICE IN EARLY (B)(6) 2025. AFTER ABOUT TWO MONTHS' ATTEMPT OF HEAD BANDAGE, THERE WAS NO CHANGE IN THE SITUATION. THEREFORE, THE USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23141189 ↗
• MalfunctionSep 9, 2025Impedance Problem; Impedance Problem

  THE USER'S PARENT REPORTED THAT THE USER WAS UNABLE TO HEAR SOUNDS WITH THE DEVICE AFTER A HEAD IMPACT. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 23002000 ↗
• MalfunctionMay 7, 2025Impedance Problem; Impedance Problem

  THE AUDIOLOGIST ASKED AN INTEGRITY TEST FOR THE USER TO CLARIFY IF THERE IS A FAILURE IN THE LEFT IMPLANT. FOR SEVERAL YEARS, IN SITU MEASUREMENTS SHOWED A PROGRESSIVE NUMBER OF CHANNELS WITH HIGH IMPEDANCE. A CT SCAN WILL BE SCHEDULED. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21974511 ↗
• MalfunctionMar 25, 2025Impedance Problem; Impedance Problem

  THE USER IS NOT RESPONDING TO SOUNDS SINCE 2 WEEKS. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686239 ↗
• MalfunctionJan 15, 2025Impedance Problem; Impedance Problem

  THE USER'S PARENT REPORTED THAT THE USER EXPERIENCED A HEAD TRAUMA ON (B)(6) 2024. AFTERWARDS, THE USER DID NOT HEAR SOUNDS WITH THE DEVICE. THE USER HAS BEEN RE-IMPLANTED.

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

  MAUDE report 21158593 ↗
• MalfunctionDec 12, 2024Circuit Failure; Circuit Failure

  THE PARENT OF THE USER REPORTED A HEAD IMPACT ON (B)(6) 2024. AFTERWARDS, AN OBVIOUS DECLINE IN HEARING PERFORMANCE WAS OBSERVED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20911783 ↗
• InjurySep 10, 2024Impedance Problem; Lack of Effect; Impedance Problem; Lack of Effect

  THE USER HAD A DECLINE IN HEARING PERFORMANCE SINCE HE CONTRACTED MENINGITIS IN (B)(6)2019. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant; Meningitis

  MAUDE report 20178678 ↗
• MalfunctionJul 29, 2024Impedance Problem; Impedance Problem

  CLINICAL SUPPORT WAS REQUESTED AFTER THE USER COMPLAINED THAT SHE WAS NOT ABLE TO HEAR PROPERLY WHEN USING THE DEVICE. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 19849489 ↗
• InjuryJul 2, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER HAD INFECTION AND IMPLANT IS EXPOSED. IT IS CONSIDERED TO PROCEED WITH EXPLANTATION AND REIMPLANTATION WITH NEW DEVICE ON OPPOSITE SIDE.

  Patient problems: Tissue Breakdown

  MAUDE report 19653195 ↗
• MalfunctionJun 4, 2024Impedance Problem; Impedance Problem

  A POSSIBLE DEVICE MALFUNCTION WAS REPORTED.

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

  MAUDE report 19456717 ↗
• MalfunctionApr 24, 2024Impedance Problem; Migration; Impedance Problem; Migration

  IT WAS REPORTED THAT THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19170839 ↗
• MalfunctionApr 4, 2024Impedance Problem; Impedance Problem

  LATEST IN SITU MEASUREMENTS FROM MARCH 19, 2023, SHOW 11 CHANNELS WITH HIGH IMPEDANCE. FURTHER PROCEEDING IS CURRENTLY UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 19039582 ↗
• MalfunctionApr 4, 2024Impedance Problem; Impedance Problem

  FOLLOWING A HEAD IMPACT ON (B)(6) 2024, A DECLINE IN THE USER'S HEARING PERFORMANCE WAS REPORTED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19039151 ↗
• MalfunctionApr 3, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE MAY BE AFFECTED.

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

  MAUDE report 19031297 ↗
• MalfunctionMar 12, 2024Impedance Problem; Impedance Problem

  SINCE SEPTEMBER 2023, THE USER'S PARENTS OBSERVED A DECLINE IN THEIR SON'S HEARING PERFORMANCE AFTER HE HAD EXPERIENCED A HEAD TRAUMA. THE USER WAS RE-IMPLANTED ON (B0(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 18884324 ↗
• MalfunctionFeb 12, 2024Impedance Problem; Impedance Problem

  THE USER INFORMED HIS PARENTS UPON RETURNING FROM SCHOOL, THAT HE HAS LOST HIS HEARING THROUGH THE IMPLANT. IT IS CURRENTLY UNKNOWN WHETHER THIS HAS BEEN CAUSED BY TRAUMA OR ACCIDENT. RE-IMPLANTATION IS CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 18684951 ↗
• MalfunctionJan 15, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WAS RE-IMPLANTED ON (B)(6).2024.

  Patient problems: Failure of Implant

  MAUDE report 18511024 ↗
• MalfunctionJan 11, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERCEPTION IS AFFECTED. THE USER WILL BE RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18490686 ↗
• MalfunctionJan 8, 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 VISITED THE CLINIC WITH BLOODY EAR DISCHARGE AND NO MORE HEARING BENEFIT WITH THE DEVICE. THE PROBLEM STARTED 10-12 DAYS PRIOR (MID DECEMBER 2023). THE USER HAS BEEN REIMPLANTED WITH A NEW DEVICE.

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

  MAUDE report 18462578 ↗
• MalfunctionNov 8, 2023Impedance Problem; Impedance Problem

  IN SITU MEASUREMETS WERE INDICATIVE OF A POSSIBLE DEVICE MALFUCNTION. THE USER HAS BEEN REIMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18092439 ↗

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-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
• 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