Mi1200 SYNCHRONY +FLEX28 09404Recalls & reported problems

Summary

The FDA's MAUDE database contains 672 adverse event reports that list this exact device (DI 09008737094041), received between Jul 2, 2018 and Sep 15, 2026 — classified as 331 injuries, 341 malfunctions.

The most frequently reported specific device problem is “Output Problem” (306 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 672 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Impedance Problem

  Hearing performance with the device is affected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768319 ↗
• InjurySep 14, 2026Impedance Problem

  In (b)(6) 2026, the user reported a decline in benefit with the device. The user was re-implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50749926 ↗
• InjurySep 11, 2026Impedance Problem

  The clinic has not specified the reason for the explantation, but states that the implant has failed. The user was reimplanted on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50730089 ↗
• InjurySep 11, 2026Impedance Problem

  The recipient reported a decrease in benefit with the device starting around (b)(6) 2026. The user will be re-implanted in (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50730087 ↗
• InjurySep 9, 2026Impedance Problem

  The user complained of a buzzing sensation with the device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50690926 ↗
• InjurySep 3, 2026Impedance Problem

  The user's hearing performance with the device is affected. The user was reimplanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50588352 ↗
• InjurySep 2, 2026Impedance Problem

  The user noticed a change in hearing performance with the device. The user was reimplanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50562726 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  The user was explanted due to an infection. Information for this case is currently limited.More information has been requested.

  Patient problems: Unspecified Infection

  MAUDE report 50544375 ↗
• InjurySep 1, 2026Migration

  The electrode array had migrated out of the cochlea leading to decreased benefit with the device.The device has been explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50538746 ↗
• MalfunctionAug 22, 2026Impedance Problem

  The user noticed a sudden change in hearing with the device. Re-implantation is scheduled for December 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50391210 ↗
• InjuryJul 31, 2026Impedance Problem

  The parent reported a sudden hearing loss with the left CI in early (b)(6) 2026. The user has been reimplanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50095999 ↗
• MalfunctionJul 30, 2026Impedance Problem

  The user's performance worsened in the last six months.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50080200 ↗
• MalfunctionJul 16, 2026Circuit Failure; Impedance Problem

  SUDDEN HEARING LOSS WITH DEVICE FOLLOWING HEAD IMPACT ON (B)(6) 2026. THE USER WAS RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 25834838 ↗
• MalfunctionJul 14, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. AN INTEGRITY TEST HAS BEEN DONE AND REIMPLANTATION HAS BEEN RECOMMENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25813002 ↗
• MalfunctionJul 2, 2026Impedance Problem

  Hearing performance with the device is affected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25688039 ↗
• MalfunctionJun 18, 2026No Device Output

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

  Patient problems: Head Injury

  MAUDE report 25542183 ↗
• MalfunctionJun 5, 2026Impedance Problem

  THE USER'S PARENT REPORTED ON 22-APR-2026 THAT THE USER COULDN'T HEAR SOUNDS WITH THE CI FOLLOWING A HEAD IMPACT NEAR THE LEFT IMPLANT. REIMPLANTATION WAS PERFORMED ON (B)(6) 2026.

  Patient problems: Head Injury

  MAUDE report 25404720 ↗
• MalfunctionJun 5, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WILL LIKELY BE REIMPLANTED, HOWEVER NO DATE FOR THE SURGERY HAS BEEN SET YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25404718 ↗
• MalfunctionMay 18, 2026Migration

  DURING THE LAST FITTING SESSION, MANY CHANNELS DID NOT PRODUCE ANY RESPONSE, WHILE OTHERS CAUSED VARYING LEVELS OF FACIAL STIMULATION. REINSERTION IS CONSIDERED, HOWEVER NO DATE HAS BEEN SCHEDULED AND IT IS STILL TO BE DETERMINED WHETHER THE SAME DEVICE WILL BE REINSERTED OR REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25198205 ↗
• MalfunctionApr 29, 2026Impedance Problem

  THE USER SHOWS LIMITED AND ABNORMAL COCHLEAR IMPLANT RESPONSES, WITH NO BEHAVIORAL HEARING RESPONSES REPORTED BY THE FAMILY. A SURGICAL CONSULTATION AND CT SCAN ARE SCHEDULED, AND REVISION SURGERY IS LIKELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027874 ↗
• MalfunctionApr 29, 2026Impedance Problem

  FOLLOWING A TRAUMA TO THE HEAD, HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. RE-IMPLANTATION IS PLANNED, BUT NO DATE HAS BEEN DISCLOSED.

  Patient problems: Head Injury

  MAUDE report 25026773 ↗
• InjuryApr 27, 2026Insufficient Device Problem Information

  THE USER HAD BEEN HOSPITALIZED WITH SWELLING BEHIND THE RIGHT EAR AND TREATED WITH BOTH AUGMENTIN AND IV ANTIBIOTICS. ALTHOUGH THE SWELLING HAS DECREASED, SHE NOW HAS A POST AURICULAR DRAINING ABSCESS BEHIND HER RIGHT EAR THAT BEEN PRESENT SINCE AT LEAST (B)(6) 2025. THE PLAN IS TO EXPLANT HER RIGHT DEVICE AND TREAT THE INFECTION.

  Patient problems: Swelling/ Edema

  MAUDE report 24998905 ↗
• MalfunctionApr 22, 2026Impedance Problem

  THE USER NOTICED FLUCTUATIONS IN HEARING WITH THE DEVICE STARTING IN 2024. REIMPLANTATION SURGERY IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954230 ↗
• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  THE USER WAS EXPLANTED BECAUSE A RIGHT-SIDED MASTOIDECTOMY WITH EAR CANAL CLOSURE DUE TO CHRONIC INFECTIONS WAS PERFORMED. THE INFECTION WAS A MASTOIDITIS AND DID NOT SPREAD TO THE LEVEL OF THE IMPLANT. ADDITIONALLY, THE ELECTRODE ARRAY HAD MIGRATED OUT OF THE COCHLEA AS CONFIRMED BY IMAGING AND IS THOUGHT TO BE THE REASON FOR POOR PERFORMANCE WITH THE DEVICE. THE USER WAS EXPLANTED AND REIMPLANTED AT A LATER POINT.

  Patient problems: Mastoiditis

  MAUDE report 24923007 ↗
• MalfunctionApr 7, 2026Impedance Problem

  THE USER NOTICED THAT THE HEARING QUALITY WITH THE DEVICE HAS DETERIORATED. THE CLINIC WILL PROCEED WITH REIMPLANTATION, NO DATE HAS BEEN SET YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800575 ↗

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 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