Mi1000 MED-EL CONCERT +MEDIUM 06272Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 09008737062729), received between Nov 27, 2015 and Aug 24, 2026 — classified as 13 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (22 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.

• InjuryAug 24, 2026Impedance Problem

  The user's parents reported sudden hearing loss with the left CI following head impact on (b)(6) 2026. After one month of observation with no improvement in the hearing performance, reimplantation was performed on (b)(6) 2026.

  Patient problems: Head Injury

  MAUDE report 50403182 ↗
• MalfunctionApr 9, 2026Impedance Problem

  HOWEVER, DURING THE FIRST DEVICE ADJUSTMENT ON (B)(6) 2025, MEASUREMENTS SHOWED ABNORMAL IMPEDANCE IN SOME CHANNELS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830011 ↗
• MalfunctionFeb 26, 2026Impedance Problem

  THE DEVICE WAS EXPLANTED.

  Patient problems: Head Injury

  MAUDE report 24452080 ↗
• MalfunctionJan 29, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207342 ↗
• MalfunctionJul 18, 2025Impedance Problem; Impedance Problem

  IN SITU MEASUREMENTS SHOWED AFFECTED CHANNELS. THE USER NEVER SHOWED ANY DISCOMFORT. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539519 ↗
• MalfunctionJul 18, 2025Impedance Problem; Impedance Problem

  THE USER'S PARENT REPORTED IN EARLY (B)(6) 2025 THAT A RECENT DECLINE IN HEARING PERFORMANCE WITH THE RIGHT COCHLEAR IMPLANT WAS OBSERVED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539513 ↗
• MalfunctionDec 30, 2024Electrical Shorting; Lack of Effect; Electrical Shorting; Lack of Effect

  THE DEVICE WAS EXPLANTED. THE USER WAS DISSATISFIED WITH ITS PERFORMANCE.

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

  MAUDE report 21034141 ↗
• MalfunctionDec 30, 2024Migration; Lack of Effect; Migration; Lack of Effect

  THE DEVICE WAS EXPLANTED. THE USER WAS DISSATISFIED WITH ITS PERFORMANCE.

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

  MAUDE report 21034026 ↗
• MalfunctionSep 13, 2024Impedance Problem; Impedance Problem

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

  Patient problems: Failure of Implant

  MAUDE report 20209980 ↗
• MalfunctionSep 3, 2024Impedance Problem; Impedance Problem

  THE USER REPORTED THAT HE COULD NOT HEAR WITH HIS DEVICE ANYMORE. EXPERT MEASUREMENTS WILL BE PLANNED TO CONFIRM A POTENTIAL DEVICE FAILURE.

  Patient problems: Failure of Implant

  MAUDE report 20123397 ↗
• MalfunctionMar 29, 2024Impedance Problem; Impedance Problem

  THE PARENTS OF THE USER REPORTED A TRAUMA IN THE REGION OF THE IMPLANT. EXPERT TELEMETRY WILL BE SCHEDULED BY THE DISTRIBUTOR TO CONFIRM THE FAILURE. RE-IMPLANTATION IS CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 19002341 ↗
• MalfunctionFeb 5, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE EXTRUSION OF THE DEVICE WAS REPORTED WHICH STARTED IN MID-JANUARY, RESULTING IN AN EXPLANTATION AND CLOSING OF THE WOUND. THE USER HAS BEEN EXPLANTED.

  Patient problems: Skin Tears

  MAUDE report 18640522 ↗
• MalfunctionOct 10, 2023Impedance Problem; Impedance Problem

  THE PARENTS REPORTED THAT THE USER WAS NO LONGER ABLE TO HEAR WITH THE DEVICE. RE-IMPLANTATION HAS BEEN SUGGESTED TO THE MEDICAL TEAM, BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 17904326 ↗
• MalfunctionAug 28, 2023Adverse 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 HAD PAIN AROUND THE COIL STARTING TWO YEARS AGO. THE USER HARDLY USED THE PROCESSOR DUE TO THE PAIN. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Extraskeletal ossification; Implant Pain

  MAUDE report 17630522 ↗
• MalfunctionJul 20, 2023Impedance Problem; Impedance Problem

  THE USER_S HEARING PERFORMANCE SUDDENLY DECREASED.

  Patient problems: Failure of Implant

  MAUDE report 17361065 ↗
• MalfunctionJul 19, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS PLANNED.

  Patient problems: Failure of Implant

  MAUDE report 17348380 ↗
• MalfunctionMay 15, 2023Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  THE USER REPORTED SHE HAD NEVER PERFORMED WELL WITH HER DEVICE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16929472 ↗
• MalfunctionMay 12, 2023Impedance Problem; Impedance Problem

  IN (B)(6) 2022, THE USER HAD A FALL AND HIT HIS HEAD ON THE IMPLANT SIDE. FURTHER MEDICAL INTERVENTION IS CONSIDERED, BUT NO DATE HAS BEEN PROVIDED YET.

  Patient problems: Failure of Implant

  MAUDE report 16917415 ↗
• MalfunctionApr 25, 2023Impedance Problem; Impedance Problem

  THE USER FELL AND HIT HER HEAD ON THE IMPLANT SITE. FOLLOWING THIS EVENT, THE PARENTS IMMEDIATELY NOTICED THAT THE CHILD WAS NOT HEARING ANYMORE WITH THE DEVICE. A RE-IMPLANTATION WILL BE PLANNED BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 16805792 ↗
• MalfunctionMar 28, 2023Impedance Problem; Impedance Problem

  ON (B)(6) 2023 THE USER ATTENDED A FITTING SESSION AND DURING THE IN SITU MEASUREMENTS, AFFECTED CHANNELS HAVE BEEN SEEN. FURTHERMORE, THE HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16626279 ↗
• MalfunctionMar 23, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED.

  Patient problems: Failure of Implant

  MAUDE report 16596639 ↗
• MalfunctionJan 30, 2023Impedance Problem; Impedance Problem

  THE USER'S FATHER REPORTED THAT AFTER A FALL, THE USER SUDDENLY STOPPED HEARING AND RESPONDING TO SPEECH ON THE AFFECTED SIDE. IT WAS SUGGESTED TO DO NOT USE THE PROCESSOR ON THAT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 16263722 ↗
• MalfunctionJan 27, 2023Impedance Problem; Insufficient Device Problem Information; Impedance Problem; Insufficient Device Problem Information

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE HAS DETERIORATED AFTER A HEAD TRAUMA WHICH OCCURRED IN (B)(6) 2020. THE USER_S PERFORMANCE WITH THE DEVICE WAS GOOD BEFORE THE EVENT OCCURRED. RE-IMPLANTATION HAS BEEN DONE ON (B)(6)2023.

  Patient problems: Failure of Implant

  MAUDE report 16252138 ↗
• MalfunctionJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT REQUESTED THE EXPLANTATION OF THE DEVICE DUE TO PAIN MORE THAN 7 YEARS AFTER IMPLANTATION. THE RECIPIENT HAS BEEN EXPLANTED ON (B)(6) 2022.

  Patient problems: Pain

  MAUDE report 16245330 ↗
• MalfunctionSep 6, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE USER PRESENTED SUDDEN DEAFNESS IN THE LEFT EAR IN 2020.

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

  MAUDE report 15362130 ↗

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