Mi1200 SYNCHRONY PIN +FLEX28 09405Recalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 09008737094058), received between Apr 20, 2015 and Sep 14, 2026 — classified as 175 injuries, 112 malfunctions.

The most frequently reported specific device problem is “Output Problem” (144 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 287 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Impedance Problem

  In situ testing showed affected channels.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50750434 ↗
• InjurySep 1, 2026Insufficient Device Problem Information

  The user was explanted due to "nonfunctional" electrode(s). At the moment information for this case is limited.

  Patient problems: Insufficient Information

  MAUDE report 50538745 ↗
• MalfunctionAug 10, 2026Impedance Problem

  Hearing performance with the device is affected, immediately after reported light head trauma from a fall. The user has been reimplanted.

  Patient problems: Head Injury

  MAUDE report 50190281 ↗
• MalfunctionJul 10, 2026Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. THE USER WILL POTENTIALLY REIMPLANTED; HOWEVER, NO DATE HAS BEEN SET YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25775477 ↗
• MalfunctionMar 9, 2026Impedance Problem

  A PROGRESSIVELY INCREASING NUMBER OF AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. THE USER WAS REIMPLANTED WITH A DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24542962 ↗
• MalfunctionJan 27, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. FURTHER TECHNICAL CHECKS ARE PLANNED.

  Patient problems: Head Injury

  MAUDE report 24189327 ↗
• InjuryJan 15, 2026Migration

  THE REPLACEMENT SURGERY WAS SCHEDULED FOR (B)(6) 2025, BUT DUE TO SEVERE INFLAMMATION, THE REPLACEMENT WAS ABANDONED. ONLY THE ELECTRODE WAS REMOVED, AND AN INSERTION ELECTRODE (MEDIUM) WAS INSERTED. ACCORDING TO THE DOCTOR, IT IS SUSPECTED THAT THE LEAD MAY HAVE TOUCHED THE EARDRUM, CAUSING INFLAMMATION AND SUBSEQUENTLY LEADING TO CHOLESTEATOMA.DURING SURGERY, ONLY THE ELECTRODE LEAD WAS REMOVED, AND A DUMMY ELECTRODE WAS INSERTED. THE HOUSING WAS PRESERVED.

  Patient problems: Inflammation

  MAUDE report 24080091 ↗
• MalfunctionDec 11, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WAS REIMPLANTED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23776569 ↗
• MalfunctionOct 29, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WAS SEEN AGAIN BY THE CLINIC AND THE USER WILL LIKELY PROCEED WITH REIMPLANTATION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411459 ↗
• MalfunctionOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER HAS BEEN EXPLANTED FOLLOWING RECURRENT TISSUE INFECTIONS AT THE IMPLANT SITE. CURRENTLY NO RE-IMPLANTATION IS PLANNED. ANTIBIOTIC TREATMENT HAS BEEN INITIATED.

  Patient problems: Unspecified Infection

  MAUDE report 23378370 ↗
• MalfunctionOct 22, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  POST-OP IMAGING REPORTEDLY SHOWED ONE EXTRA-COCHLEAR CHANNEL. THEREFORE, THE USER REQUESTED REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23355433 ↗
• MalfunctionSep 26, 2025Circuit Failure; Circuit Failure

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23154354 ↗
• MalfunctionSep 5, 2025Impedance Problem; Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977302 ↗
• MalfunctionJul 28, 2025Migration; Migration

  THE USER REPORTED BAD SOUND QUALITY AND INTERMITTENCY WITH THE DEVICE. OTOPLAN INDICATE SHALLOW INSERTION/EXTRA-COCHLEAR CHANNELS. THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637189 ↗
• MalfunctionJul 8, 2025Impedance Problem; Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437817 ↗
• MalfunctionJun 26, 2025Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. ACCORDING TO NEW INFORMATION THE USER WILL BE REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22334828 ↗
• MalfunctionMay 20, 2025Impedance Problem; Impedance Problem

  THE USER WAS IN THE CLINIC FOR AN UNRELATED EMERGENCY INVOLVING A PLASTIC OBJECT LODGED IN HIS EAR CANAL, DURING WHICH AN IMPLANT FAILURE WAS INCIDENTALLY DISCOVERED. DESPITE ELECTRODE STIMULATION, NO RESPONSE WAS OBSERVED. THE USER WAS RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22050124 ↗
• MalfunctionMay 19, 2025Impedance Problem; Impedance Problem

  THE USER NOTICED A GRADUAL DECREASE IN HEARING PERFORMANCE WITH THE DEVICE. REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041641 ↗
• MalfunctionMar 4, 2025Impedance Problem; Impedance Problem

  THE USER HAS HEARD A _WHOOSHING_ AND _WHISTLING_ SOUND BEGINNING IN SEPTEMBER 2024. AFTER A MAPPING APPOINTMENT IN OCTOBER, THE "WHOOSHING" SOUND WENT AWAY BUT THEN CAME BACK ALONG WITH A "WHISTLE" SOUND THAT IS ALWAYS IN THE BACKGROUND. THE USER'S PROGRESS HAS BEEN MONITORED SINCE FALL 2024 UNTIL FEBRUARY 2025 WITH MAPPING CHANGES NOT IMPROVING SUBJECTIVE OR OBJECTIVE USER PERFORMANCE WITH LEFT CI. AS THE USER'S PROGRESS CONTINUES TO DECLINE, THE CLINIC AGREES THAT RE-IMPLANTATION IS NECESSARY, BUT NO DATE HAS BEEN SCHEDULED YET.

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

  MAUDE report 21514413 ↗
• MalfunctionJan 28, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED AFTER A TRAUMA TO THE HEAD. THE CLINIC WILL REIMPLANT THE USER BUT HAS NOT SET A DATE FOR THE REVISION SURGERY YET.

  Patient problems: Failure of Implant

  MAUDE report 21250319 ↗
• MalfunctionJan 16, 2025Impedance Problem; Impedance Problem

  THE USER NOTICED A CHANGE IN HEARING PERFORMANCE WITH THE DEVICE IN (B)(6) 2024. THE USER WAS REIMPLANTED ON (B)(6) 2025.

  Patient problems: Failure of Implant

  MAUDE report 21168856 ↗
• MalfunctionJan 13, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA TO THE HEAD ON (B)(6) 2025. IN SITU MEASUREMENTS FROM (B)(6) 2025 SHOWED 10 CHANNELS WITH HIGH IMPEDANCE.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 21138036 ↗
• MalfunctionJan 8, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER'S FAMILY REPORTS THAT THE DEVICE IS NO LONGER PROVIDING ANY BENEFIT. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 21101808 ↗
• MalfunctionDec 31, 2024Impedance Problem; Impedance Problem

  OVER THE LAST SIX MONTHS, THE HEARING PERFORMANCE OF THE DEVICE HAS CONTINUOUSLY WORSENED. IN (B)(6) 2025, A CT SCAN WILL BE PERFORMED TO CHECK THE ARRAY POSITION. RE-IMPLANTATION SURGERY IS BEING CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

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

  MAUDE report 21046394 ↗
• MalfunctionDec 16, 2024Impedance Problem; Impedance Problem

  THE USER CURRENTLY HAS NO HEARING BENEFIT WITH THE DEVICE. A REVISION SURGERY IS BEING CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 20937498 ↗

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