Mi1000 MED-EL CONCERT +FLEXsoft 06276Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 09008737062767), received between Jul 26, 2018 and May 8, 2026 — classified as 19 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Output Problem” (26 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Impedance Problem

  THE USER EXPERIENCED SUDDEN HEARING LOSS WITH RIGHT CI FOLLOWING A HEAD IMPACT IN EARLY (B)(6) 2026. NO SWELLING OR REDNESS WAS SEEN. AFTER ONE MONTH OF OBSERVATION WITH NO IMPROVEMENT IN HEARING PERFORMANCE, RE-IMPLANTATION WAS DONE ON (B)(6) 2026.

  Patient problems: Head Injury

  MAUDE report 25120633 ↗
• MalfunctionApr 28, 2026Impedance Problem

  THE USER EXPERIENCED SUDDEN HEARING LOSS WITH THE LEFT CI AFTER HEAD IMPACT ON (B)(6) 2026. AFTER ONE MONTH OF OBSERVATION WITH NO HEARING IMPROVEMENT, REIMPLANTATION WAS PERFORMED ON (B)(6) 2026.

  Patient problems: Head Injury

  MAUDE report 25017123 ↗
• MalfunctionMar 3, 2026Malposition of Device; Migration

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493629 ↗
• MalfunctionJan 26, 2026Impedance Problem

  THE DEVICE WAS EXPLANTED DUE TO A HEAD TRAUMA.

  Patient problems: Head Injury

  MAUDE report 24176711 ↗
• MalfunctionJan 8, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000976 ↗
• MalfunctionDec 29, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23905148 ↗
• MalfunctionNov 11, 2025Impedance Problem; Impedance Problem

  THE USER REPORTED SUDDEN HEARING LOSS WITH THE AFFECTED DEVICE FOLLOWING A HEAD IMPACT ON (B)(6) 2025. THE USER UNDERWENT REIMPLANTATION.

  Patient problems: Head Injury

  MAUDE report 23520457 ↗
• MalfunctionOct 24, 2025Impedance Problem; Insufficient Device Problem Information; Impedance Problem; Insufficient Device Problem Information

  THERE WAS A LOSS OF SOUND IN THE LEFT EAR APPROXIMATELY THREE WEEKS AGO. THERE WERE NO EVENTS OR FACTORS THAT COULD BE LINKED TO THE CHANGE IN HEARING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376912 ↗
• MalfunctionDec 30, 2024Impedance Problem; Impedance Problem

  THE PARENT REPORTED A DECLINE IN HEARING PERFORMANCE WITH THE CI WAS OBSERVED AFTER A HEAD TRAUMA ON (B)(6) 2024. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 21034021 ↗
• MalfunctionNov 27, 2024Impedance Problem; Impedance Problem

  THE USER REPORTED AROUND JUN-2024 A SLIGHT DECLINE IN HEARING. BY SEPTEMBER THE DECLINE WAS OBVIOUS, THE SOUND QUALITY WAS POOR AND SOMETIME NOISY. RE-IMPLANTATION IS CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 20796543 ↗
• MalfunctionSep 30, 2024Impedance Problem; Impedance Problem

  PER THE PARENT THE USER WAS SUDDENLY UNABLE TO HEAR SOUNDS WITH THE DEVICE. A HISTORY OF TRAUMA WAS DENIED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20332997 ↗
• MalfunctionAug 28, 2024Impedance Problem; Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20083233 ↗
• MalfunctionAug 21, 2024Impedance Problem; Impedance Problem

  THE PARENT REPORTED THAT THE USER WAS UNABLE TO HEAR SOUNDS WITH THE DEVICE. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20019378 ↗
• InjuryJun 24, 2024Device Appears to Trigger Rejection; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Insufficient Device Problem Information

  REPORTEDLY, THE SKIN OVER THE IMPLANT HOUSING WAS DEFECTIVE. THE DEVICE WAS EXPLANTED ON (B)(6) 2024.

  Patient problems: Insufficient Information; Skin Tears

  MAUDE report 19592526 ↗
• MalfunctionJun 27, 2023Impedance Problem; Impedance Problem

  PER THE PARENTS A DECLINE IN THE HEARING PERFORMANCE OF THE USER WAS OBSERVED STARTING IN (B)(6) 2021. THE USER HAS BEEN RE-IMPLANTED.

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

  MAUDE report 17206888 ↗
• MalfunctionApr 19, 2023Impedance Problem; Impedance Problem

  ACCORDING TO THE PARENTS, THE USER FELL DOWN AND HIT THE IMPLANTATION SITE ON (B)(6)2023. SINCE THEN HE COULDN'T HEAR SOUNDS WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 16768557 ↗
• MalfunctionMar 17, 2023Electrical Shorting; Impedance Problem; Electrical Shorting; Impedance Problem

  THE HEARING PERFORMANCE WITH THE DEVICE DECREASED NOTICEABLE. DUE TO AGE OF THE PATIENT NOT FURTHER MEDICAL INTERVENTION IS SCHEDULED AND NEXT APPOINTMENT IS CALLED IN ONE YEAR.

  Patient problems: Failure of Implant

  MAUDE report 16563290 ↗
• MalfunctionMar 15, 2023Impedance Problem; Impedance Problem

  THE USER EXPERIENCED A WORSENING OF THE HEARING PERFORMANCE WITH THE DEVICE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16544742 ↗
• MalfunctionNov 14, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  AT THE END OF OCTOBER 2022 THE USER SUSTAINED A BLOW TO HIS HEAD AFTER WHICH HE COULD NO LONGER HEAR WITH THE DEVICE. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15788783 ↗
• MalfunctionSep 20, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  DURING A STANDARD FOLLOW-UP, IN SITU MEASUREMENTS SHOWED AFFECTED CHANNELS. NO ACCIDENT OR TRAUMA HAVE BEEN REPORTED. REIMPLANTATION IS CONSIDERED BUT NOT YET SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 15455127 ↗
• MalfunctionAug 30, 2022Output Problem; Output Problem

  THE USER HAD A HEAD TRAUMA IN THE FIRST HALF OF 2021, IN SITU MEASUREMENTS FROM APRIL 2021 SHOWED ABNORMAL RESULTS AND THE USER SHOW POOR AUDITORY RESPONSES. THE USER WAS RE-IMPLANTED WITH A NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 15318500 ↗
• MalfunctionJul 1, 2022Output Problem; Output Problem

  THE USER WAS NOT RESPONDING TO SOUNDS IN MID-(B)(6) 2022 AND THE IN-SITU MEASUREMENTS SHOW ABNORMAL RESULTS. THE USER HAS BEEN REIMPLANTED ON (B)(6) 2022, WITH A NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 14883381 ↗
• MalfunctionJan 27, 2022Output Problem; Output Problem

  THE USER REPORTS THAT THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. A REIMPLANTATION SURGERY IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 13363919 ↗
• InjuryDec 23, 2021Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information

  THE RECIPIENT HAS BEEN REIMPLANTED WITH A NEW DEVICE ON (B)(6)2021. AS PER EXPLANT REPORT FORM THE EXPLANTATION WAS DUE TO LOSS OF FUNCTION.

  Patient problems: Failure of Implant

  MAUDE report 13075426 ↗
• MalfunctionNov 30, 2021Output Problem; Output Problem

  DURING AN APPOINTMENT IN (B)(6) 2021, IT WAS NOTED THAT THE RECIPIENT HAD A POOR AUDITORY RESPONSE AND THE IN-SITU MEASUREMENTS SHOWED ABNORMAL RESULTS. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12893292 ↗

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