Mi1000 MED-EL CONCERT PIN +FLEXsoft 06275Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 09008737062750), received between Apr 18, 2019 and Jun 26, 2025 — classified as 5 injuries, 15 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Impedance Problem; Impedance Problem

  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 22334665 ↗
• MalfunctionFeb 14, 2025Impedance Problem; Impedance Problem

  THE USER COMPLAINT OF DECREASED SPEECH INTELLIGIBILITY ON THE RIGHT SIDE.

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

  MAUDE report 21383087 ↗
• MalfunctionNov 19, 2024Impedance Problem; Impedance Problem

  THE USER HAD A SUDDEN LOSS OF HEARING SENSATION. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 20721351 ↗
• MalfunctionOct 10, 2023Impedance Problem; Impedance Problem

  DURING IN SITU TESTING, AFFECTED CHANNELS WERE SEEN. RE-IMPLANTATION IS CONSIDERED BUT HAS NOT BEEN SCHEDULED YET.

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

  MAUDE report 17904047 ↗
• MalfunctionOct 10, 2023Impedance Problem; Impedance Problem

  DURING IN SITU TESTING, AFFECTED CHANNELS WERE SEEN. THE USER HAS BEEN REIMPLANTED WITH A NEW DEVICE.

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

  MAUDE report 17904046 ↗
• MalfunctionJul 13, 2023Impedance Problem; Impedance Problem

  THE USER REPORTS NO HEARING PERCEPTION WITH USING THE DEVICE. RE-IMPLANTATION IS CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

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

  MAUDE report 17314690 ↗
• MalfunctionJan 25, 2023Impedance Problem; Impedance Problem

  DURING AN UPGRADE FITTING SESSION, ALL CHANNELS WERE FOUND WITH HIGH IMPEDANCE. THE DATE OF REIMPLANTATION HAS NOT BEEN SCHEDULED YET AND IT WILL LIKELY PLACE IN 2-3 MONTHS.

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

  MAUDE report 16239191 ↗
• MalfunctionJan 2, 2023Impedance Problem; Impedance Problem

  THE USER HAS BEEN RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2021. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16082832 ↗
• MalfunctionNov 30, 2022Output Problem; Output Problem

  INITIAL INFORMATION HAD BEEN RECEIVED THAT FURTHER MEDICAL INTERVENTION IS CONSIDERED. IT IS UNKNOWN IF THERE HAD BEEN A CHANGE IN THE RECIPIENTS HEARING PERFORMANCE WITH THE DEVICE OR IF AN ACCIDENT OR TRAUMA OCCURRED. THE RECIPIENT HAS BEEN REIMPLANTED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 15885521 ↗
• MalfunctionSep 23, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER REPORTED NO HEARING SENSATION WITH THE DEVICE. RE-IMPLANTATION IS CONSIDERED BUT NOT YET SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 15473547 ↗
• MalfunctionSep 12, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER SUFFERED FROM A HEAD TRAUMA WHILE PLAYING AT SCHOOL AND HAS NO HEARING SENSATION SINCE. RE-IMPLANTATION IS CONSIDERED, BUT NOT SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 15402148 ↗
• MalfunctionJun 7, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER REPORTED HAVING NO HEARING SENSATION WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 14617865 ↗
• MalfunctionApr 26, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  REPORTEDLY, THE USER DOES NOT HAVE ANY HEARING SENSATION.

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

  MAUDE report 14206540 ↗
• MalfunctionApr 19, 2022Output Problem; Output Problem

  INITIAL INFORMATION ABOUT A POSSIBLE RE-IMPLANTATION HAS BEEN RECEIVED. THE EXPLANTED DEVICE HAS BEEN RECEIVED FOR INVESTIGATION ON (B)(6), 2022. AS OF (B)(6), 2022 NO FURTHER INFORMATION HAS BEEN RECEIVED, DESPITE REQUEST.

  Patient problems: Failure of Implant

  MAUDE report 14141143 ↗
• InjuryJun 10, 2021Output Problem; Output Problem

  THE USER HAS BEEN RE-IMPLANTED ON (B)(6) 2021. NO FURTHER INFORMATION HAS BEEN RECEIVED, DESPITE REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 11974871 ↗
• MalfunctionJan 30, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE RECIPIENT WAS IMPLANTED IN 2014 BUT WAS NOT ABLE TO HEAR WELL WITH THE DEVICE AFTER IMPLANTATION AND SPEECH DISCRIMINATION DID NOT DEVELOP. RE-FITTING WAS DONE BUT THE ISSUE WAS NOT RESOLVED. AFTER MORE REFITTING THE USER WAS ABLE TO HEAR SOUNDS BETTER BUT THERE WAS STILL NO SPEECH DISCRIMINATION. THE RECIPIENT REQUESTED TO HAVE THE DEVICE EXPLANTED.

  Patient problems: Failure of Implant; No Information

  MAUDE report 9646434 ↗
• InjuryNov 25, 2019Output Problem; Output Problem

  THE CHILD SUDDENLY NO LONGER HAD ACCESS TO SOUND WITH THE DEVICE SINCE APPROXIMATELY (B)(6) 2019. THE RECIPIENT WAS RE-IMPLANTED ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 9369902 ↗
• InjurySep 10, 2019Output Problem; Output Problem

  THE HEARING PERFORMANCE WITH THE DEVICE BECAME WORSE DUE TO NOISE. SUBSEQUENTLY THERE WAS A COMPLETE LOSS OF ACCESS TO SOUND WITH THE DEVICE. THE RECIPIENT WAS RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 8978697 ↗
• InjuryJul 4, 2019Output Problem; Output Problem

  IN WAS REPORTED IN JUNE 2019 THAT THE USER STOPPED RESPONDING TO SOUND WITH THE DEVICE 10 DAYS PRIOR. NO SWELLING OR REDNESS OVER THE IMPLANT SITE WAS NOTED. THE USER WAS RE-IMPLANTED ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 8762404 ↗
• InjuryApr 18, 2019Output Problem; Insufficient Device Problem Information; Output Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE USER HIT HIS HEAD DURING SPORT PRACTICE. THE USER WAS RE-IMPLANTED ON (B)(6) 2019. IT WAS STATED IN THE DEVICE EXPLANTATION REPORT THAT THE ACTIVE ELECTRODE LEAD WAS SEVERED DURING REMOVAL SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 8526382 ↗

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-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-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