Mi1200 SYNCHRONY +FLEX24 09400Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 09008737094003), received between Sep 5, 2018 and Jul 14, 2026 — classified as 51 injuries, 60 malfunctions.

The most frequently reported specific device problem is “Output Problem” (62 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Impedance Problem

  The user's hearing performance with the device is affected. The user's mother reported a possible fall. Reimplantation surgery is likely, but no date has been scheduled yet.

  Patient problems: Head Injury

  MAUDE report 25812338 ↗
• MalfunctionApr 9, 2026Migration

  THE USER VISITED THE CLINIC IN (B)(6) 2026 TO CHECK FOR EAR INFECTION (OTITIS MEDIA). DURING THE CHECK-UP A PORTION OF THE ELECTRODE ARRAY HAD MIGRATED OUT OF THE COCHLEA. RE-IMPLANTATION SURGERY WAS PERFORMED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829351 ↗
• MalfunctionMar 11, 2026Adverse Event Without Identified Device or Use Problem

  In (b)(6) 2025, the user began experiencing a high-pitched tinnitus, a high pitched "chirp" sound, taste disturbance (metallic taste), pain and speech degradation. The user was reimplanted. Per explanation report, two channels were found extra-cochlear at explantation.

  Patient problems: Tinnitus

  MAUDE report 24566613 ↗
• MalfunctionFeb 12, 2026Impedance Problem

  THE HEARING PERFORMANCE IS AFFECTED. REIMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24321758 ↗
• MalfunctionJan 30, 2026Impedance Problem

  INTRAOPERATIVE IN SITU MEASUREMENTS REVEALED POSSIBLE SHORT CIRCUITS ON SEVERAL CHANNELS. AN ATTEMPT TO RE-IMPLANT THE DEVICE WAS MADE, BUT IN SITU MEASUREMENTS AND MEASUREMENTS IN SALINE SOLUTION STILL SHOWED POSSIBLE SHORT CIRCUITS. A BACKUP IMPLANT WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219957 ↗
• MalfunctionJan 14, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068118 ↗
• InjuryDec 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER'S ELECTRODE ARRAY HAS EXTRUDED PAST POST-AURICULAR SKIN IN 2025, PER SURGEON THIS IS RELATED TO RECIPIENT_S MEDICAL HISTORY OF WHOLE BRAIN RADIATION, POOR SKIN QUALITY AND GRAFT REABSORPTION. REIMPLANTATION IS SCHEDULED FOR (B)(6) 2025. THIS REPORT REFERS TO 9710014-2025-01159. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Skin Tears

  MAUDE report 23800408 ↗
• InjuryDec 12, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER'S ELECTRODE ARRAY HAS EXTRUDED PAST POST-AURICULAR SKIN IN 2025, PER SURGEON THIS IS RELATED TO RECIPIENT_S MEDICAL HISTORY OF WHOLE BRAIN RADIATION, POOR SKIN QUALITY AND GRAFT REABSORPTION. THE USER WAS REIMPLANTED.

  Patient problems: Skin Tears

  MAUDE report 23786972 ↗
• MalfunctionDec 3, 2025Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. THE USER WILL BE REIMPLANTED, SO FAR THE CLINIC HAS NOT SCHEDULED A DATE FOR THE SURGERY. THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704141 ↗
• MalfunctionSep 19, 2025Impedance Problem; Impedance Problem

  The user reported persistent pain over an extended period, as well as intermittent disconnections between the implant and the external device. The user has been reimplanted.

  Patient problems: Pain

  MAUDE report 23093667 ↗
• MalfunctionJul 31, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. FURTHER PROCEEDINGS ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675107 ↗
• MalfunctionJun 23, 2025Impedance Problem; Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AND IN SITU TESTING SHOWS AFFECTED CHANNELS. THE USER HAS BEEN REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307642 ↗
• MalfunctionApr 2, 2025Impedance Problem; Migration; Impedance Problem; Migration

  ON THE (B)(6) 2025 THE RECIPIENT HAD A FALL AND HIT THE RIGHT SIDE OF HER HEAD OVER THE IMPLANT. SHE SUSTAINED AN INJURY TO RIGHT SIDE OF HER HEAD RESULTING IN A LARGE HAEMATOMA. THE USER IS SCHEDULED FOR REIMPLANTATION SURGERY ON (B)(6) 2025.

  Patient problems: Head Injury

  MAUDE report 21750919 ↗
• MalfunctionMar 14, 2025Impedance Problem; Impedance Problem

  THE USER'S LEFT IMPEDANCES HAVE CONTINUALLY INCREASED SINCE 2020 AND 9 CHANNELS CAN NO LONGER BE STIMULATED. THERE IS NO MORE HEARING ON THIS EAR. THE USER WAS REIMPLANTED WITH A DEVICE FROM ANOTHER MANUFACTURER ON (B)(6) 2025, FOR A STIFFER ELECTRODE.

  Patient problems: Failure of Implant; Mastoiditis

  MAUDE report 21604079 ↗
• MalfunctionFeb 11, 2025Migration; Migration

  THE USER'S ELECTRODE ARRAY REPORTEDLY MIGRATED OUT OF THE COCHLEA DUE TO OTITIS MEDIA. THE USER WAS REIMPLANTED ON (B)(6) 2025.

  Patient problems: Infectious Otitis Externa

  MAUDE report 21353392 ↗
• MalfunctionDec 16, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. AFTER RE-PROGRAMMING ON (B)(6) 2024, THE USER STILL COMPLAINS ABOUT HEARING BEING TOO SOFT AND SPEECH BEING UNCLEAR. THE CLINIC WILL DISCUSS PLANS FOR A EXPLANTATION OR RE-IMPLANTATION WITH THE USER.

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

  MAUDE report 20937497 ↗
• MalfunctionNov 22, 2024Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS.

  Patient problems: Failure of Implant

  MAUDE report 20755757 ↗
• MalfunctionNov 22, 2024Impedance Problem; Impedance Problem

  THE USER REPORTED NO HEARING BENEFIT WITH THE DEVICE IN MID (B)(6) 2024. REVISION SURGERY TOOK PLACE ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 20755755 ↗
• MalfunctionSep 5, 2024Insufficient Device Problem Information; Migration; Insufficient Device Problem Information; Migration

  THE USER REPORTED LIMITED BENEFIT FROM THE DEVICE. SHE HAS NOT WORN THE PROCESSOR FOR ABOUT 1 YEAR.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 20143448 ↗
• MalfunctionAug 22, 2024Migration; Migration

  THE USER HAS A HISTORY OF COMPLAINING ABOUT POOR SOUND QUALITY DESPITE EXTENSIVE PROGRAMMING OVER SEVERAL YEARS. THE CLINIC COMMUNICATED THAT THE USER IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 20029960 ↗
• MalfunctionAug 5, 2024Impedance Problem; Impedance Problem

  THE USER REPORTED THAT THEIR RIGHT COCHLEAR IMPLANT WAS NOT FUNCTIONING PROPERLY, AND AUDIO METRIC BOOTH TESTING CONFIRMED NO RESPONSE TO AUDIO STIMULI. AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19904216 ↗
• MalfunctionJul 29, 2024Impedance Problem; Impedance Problem

  THE USER IS EXPERIENCING INTERMITTENT HEARING WITH THE DEVICE AFTER A FALL. REIMPLANTATION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 19849215 ↗
• InjuryMay 17, 2024Device Appears to Trigger Rejection; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Insufficient Device Problem Information

  THE DEVICE WAS EXPLANTED IN AN EMERGENCY SURGERY ON 01-MAY-2024. REPORTEDLY, THERE WAS A WOUND OVER THE IMPLANT. MORE DETAILS TO FOLLOW.RE-IMPLANTATION IS BEING CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Tissue Breakdown

  MAUDE report 19339516 ↗
• MalfunctionMar 22, 2024Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. THE USER'S HEARING PERFORMANCE WITH THE DEVICE HAS IMPROVED AFTER ADJUSTMENTS AND REIMPLANTATION IS NOT CONSIDERED AT THE MOMENT.

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

  MAUDE report 18957622 ↗
• MalfunctionMar 20, 2024Impedance Problem; Impedance Problem

  THE USER_S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. NO INFORMATION ON POSSIBLE FURTHER STEPS HAS BEEN RECEIVED SO FAR.

  Patient problems: Failure of Implant

  MAUDE report 18939181 ↗

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 Product
• 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. Mi1000 CONCE
• 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