Mi1200 SYNCHRONY +MEDIUM 09398Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 09008737093983), received between Nov 29, 2018 and Feb 26, 2026 — classified as 8 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. REIMPLANTATION SURGERY IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452090 ↗
• MalfunctionFeb 3, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED. NO INCIDENT OR TRAUMA REPORTED. REIMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246894 ↗
• MalfunctionJan 26, 2026Circuit Failure

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED AFTER BEING HIT BY AN ELECTRIC BIKE. THE USER WAS REIMPLANTED.

  Patient problems: Head Injury

  MAUDE report 24176233 ↗
• MalfunctionJun 10, 2025Impedance Problem; Impedance Problem

  THE USER HAS NO SOUND PERCEPTION WITH THE DEVICE SINCE APPROXIMATELY (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176285 ↗
• InjuryMay 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT HAD OTITIS MEDIA WHICH HAD SPREAD TO THE LEVEL OF THE IMPLANT AND INVADED THE ELECTRODES. THE USER WAS EXPLANTED ON (B)(6) 2025. AS THERE WAS SEVERE INFLAMMATION RE-IMPLANTATION WAS PUT ON HOLD UNTIL IT IS COMPLETELY HEALED.

  Patient problems: Infectious Otitis Media

  MAUDE report 22000564 ↗
• MalfunctionJul 18, 2024Impedance Problem; Impedance Problem

  ACCORDING TO LIMITED AVAILABLE INFORMATION RE-IMPLANTATION IS BEING CONSIDERED. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 19770337 ↗
• MalfunctionMay 22, 2024Impedance Problem; Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER TRAUMA. THE USER WAS RE-IMPLANTED ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 19369257 ↗
• MalfunctionMay 22, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. FURTHER INFORMATION WILL FOLLOW FROM THE CLINIC.

  Patient problems: Failure of Implant

  MAUDE report 19369122 ↗
• MalfunctionApr 23, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA. THE USER NOTICED A SUDDEN CHANGE IN HEARING WITH THE DEVICE.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 19163859 ↗
• MalfunctionJan 9, 2024Impedance Problem; Impedance Problem

  THE USER_S HEARING PERFORMANCE WITH THE DEVICE HAS BEEN DECLINING OVER THE YEARS, WITH A SIGNIFICANT DROP SINCE AUGUST 2023. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18475596 ↗
• MalfunctionDec 21, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED AFTER A TRAUMA TO THE HEAD ON (B)(6)2023. RE-IMPLANTATION WAS PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 18370800 ↗
• MalfunctionJul 7, 2023Impedance Problem; Impedance Problem

  THE USER REPORTS LOW AUDIO VOLUME AND SHOWS NO RESPONSE TO STIMULATION DURING IN SITU TESTING. NO TRAUMA WAS REPORTED. "FURTHER" MEDICAL INTERVENTION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 17276602 ↗
• InjurySep 10, 2021Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER UNDERWENT A REVISION SURGERY TO REPAIR THE SKIN FLAP ON THE (B)(6) 2021 DUE TO EXPOSURE OF THE DEVICE. THE IMPLANT HOUSING HAD PARTIALLY EXTRUDED THROUGH THE SKIN.

  Patient problems: Skin Tears; Unspecified Infection

  MAUDE report 12451978 ↗
• InjuryAug 11, 2021Migration; Migration

  REPORTEDLY THE USER'S ELECTRODE ARRAY HAD MIGRATED COMPLETELY OUT OF THE COCHLEA AND WAS SEEN THROUGH OTOSCOPY. THE DEVICE WAS EXPLANTED ON (B)(6) 2021 FOR NOW THERE ARE NO PLANS TO RE-IMPLANT THE USER.

  Patient problems: Failure of Implant

  MAUDE report 12306645 ↗
• InjuryJan 25, 2021Device Appears to Trigger Rejection; Insufficient Device Problem Information; Device Appears to Trigger Rejection; Insufficient Device Problem Information

  DEVICE WAS EXPLANTED ON (B)(6), 2021 DUE TO EXTRUSION OF THE DEVICE THROUGH THE SKIN. AN EXTRUSION WAS FIRST SEEN ON THE (B)(6) 2020. BEFORE DEVICE EXTRUSION THE HEARING PERFORMANCE WITH THE DEVICE WAS GOOD. THE USER WAS RE-IMPLANTED.

  Patient problems: Insufficient Information; Tissue Breakdown

  MAUDE report 11221470 ↗
• InjuryDec 9, 2020Output Problem; Output Problem

  REPORTEDLY, THE USER STARTED TO EXPERIENCE A DECREASE IN HEARING PERFORMANCE WITH THE DEVICE IN SUMMER. THE USER WAS RE-IMPLANTED ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10974322 ↗
• MalfunctionDec 11, 2019Output Problem; Output Problem

  DURING A ROUTINE FOLLOW-UP APPOINTMENT AFFECTED CHANNELS WERE FOUND. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED DUE TO THE GENERAL HEALTH CONDITION OF THE RECIPIENT.

  Patient problems: Failure of Implant

  MAUDE report 9450027 ↗
• InjurySep 12, 2019Output Problem; Output Problem

  USER REPORTED DECREASED HEARING PERFORMANCE FOLLOWING A SHUNT REMOVAL. FLUID IS VISIBLY POOLED AT THE BASE OF THE RECIPIENTS NECK BELOW THE IMPLANT. THERE IS HOWEVER NO FLUID ACCUMULATION OVER THE IMPLANT ITSELF. THE USER'S DETECTION LEVELS ARE UNCHANGED HOWEVER SPEECH MEASURES ARE UNRELIABLE. THE DEVICE HAS BEEN EXPLANTED. THIS REPORT REFERS TO 9710014-2019-00234. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 9005838 ↗
• InjuryMar 19, 2019Output Problem; Output Problem

  USER REPORTED DECREASED HEARING PERFORMANCE FOLLOWING A SHUNT REMOVAL. FLUID IS VISIBLY POOLED AT THE BASE OF THE RECIPIENTS NECK BELOW THE IMPLANT. THERE IS HOWEVER NO FLUID ACCUMULATION OVER THE IMPLANT ITSELF. THE USER'S DETECTION LEVELS ARE UNCHANGED HOWEVER SPEECH MEASURES ARE UNRELIABLE.

  Patient problems: Failure of Implant

  MAUDE report 8432152 ↗
• InjuryNov 29, 2018Output Problem; Output Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. DURING A SPEECH THERAPY SESSION ON (B)(6) 2018, THE USER WAS UNABLE TO REPEAT LING SOUNDS. THERE WAS NO REPORT OF A HEAD INJURY. THE PARENT NOTICED THAT DIFFICULTIES WITH HEARING STARTED THAT DAY.

  Patient problems: Failure of Implant

  MAUDE report 8114923 ↗

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-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
• 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