Mi1210 SYNCHRONY ST +MEDIUM 33183Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 09008737331832), received between Oct 22, 2018 and Sep 11, 2026 — classified as 33 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Output Problem” (50 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50726094 ↗
• InjuryMay 7, 2026Device Appears to Trigger Rejection

  SINCE THE IMPLANTATION SURGERY, THE USER HAD RECURRING INFECTION. THE DEVICE WAS EXPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 25108680 ↗
• MalfunctionFeb 3, 2026Impedance Problem

  HEARING PERFORMANCE IS AFFECTED AFTER TRAUMA.

  Patient problems: Head Injury

  MAUDE report 24245044 ↗
• MalfunctionNov 10, 2025Impedance Problem; Impedance Problem

  IN SITU TESTING SHOWED AFFECTED CHANNELS. A RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508549 ↗
• MalfunctionNov 6, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA TO THE HEAD. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 20618840 ↗
• MalfunctionSep 26, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: Failure of Implant

  MAUDE report 20309455 ↗
• MalfunctionSep 20, 2024Impedance Problem; Impedance Problem

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

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

  MAUDE report 20265177 ↗
• MalfunctionAug 21, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A HEAD TRAUMA IN MAY 2024. RE-IMPLANTATION IS PLANNED, BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 20010349 ↗
• MalfunctionAug 9, 2024Migration; Migration

  THE USER WAS FITTED WITH 8 ACTIVE CHANNELS DURING HER FIRST FITTING. OVER TIME, THE NUMBER OF CHANNELS USED DECREASED. CURRENTLY SHE IS USING 4 ACTIVE CHANNELS. REPORTEDLY, THERE ARE SEVERAL EXTRA-COCHLEAR CHANNELS. THE SURGEON PLANS TO PERFORM A REVISION SURGERY, BUT ALSO A BACK-UP DEVICE HAS BEEN REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 19947584 ↗
• MalfunctionMay 21, 2024Impedance Problem; Impedance Problem

  THE USERS HEARING PERFORMANCE DECREASED. THERE IS NO REPORT OF SPECIFIC TRAUMA. THERE IS NO SWELLING OR REDNESS OVER THE IMPLANT AREA. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 19359981 ↗
• MalfunctionJan 15, 2024Impedance Problem; Impedance Problem

  THE USER FELL OUT OF HIS BED AND HIT HIS HEAD ON THE WARDROBE.

  Patient problems: Failure of Implant

  MAUDE report 18510108 ↗
• MalfunctionDec 27, 2023Impedance Problem; Impedance Problem

  APPROXIMATELY ONE MONTH AGO (B)(6) 2023), THE USER HAD A HEAD TRAUMA ON THE CONTRA-LATERAL SIDE. DESPITE THIS, THE USER CONTINUED TO USE THE IMPLANT WITHOUT INTERRUPTION. ONE WEEK AGO (MID (B)(6) 2023), THE USER HAD AN OTITIS INFECTION ON THE CONTRA-LATERAL SIDE. THE USER ATTENDED A ROUTINE APPOINTMENT ON (B)(6) 2023, REPORTING NO ISSUES WITH THE IMPLANT'S FUNCTIONALITY. DURING THE APPOINTMENT, AN AUDIOLOGIST CONDUCTED A FREE FIELD THRESHOLD AUDIOMETRY TEST ON BOTH SIDES INDIVIDUALLY, YIELDING SIMILAR RESULTS FOR EACH EAR: 20DB, 20DB, 15DB, 20DB, 15DB, 15DB, 15DB, 15DB.

  Patient problems: Failure of Implant

  MAUDE report 18398073 ↗
• MalfunctionDec 20, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE HAS BEEN DECREASING OVER THE PAST 2 YEARS. CURRENTLY THE USER DOES NOT HAVE ACCESS TO SOUND. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18362081 ↗
• MalfunctionOct 18, 2023Impedance Problem; Impedance Problem

  ON (B)(6) 2023, THE USER CAME TO THE CLINIC FOR A ROUTINE APPOINTMENT WHERE CHANNELS WITH ABNORMAL IMPEDANCES WERE DISCOVERED. IN ADDITION, A GOOD ECAP RESPONSE COULDN'T BE OBSERVED.

  Patient problems: Failure of Implant

  MAUDE report 17955617 ↗
• MalfunctionSep 21, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A HEAD TRAUMA OCCURRED. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 17786842 ↗
• MalfunctionSep 14, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA OCCURRED ON (B)(6) 2023.

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

  MAUDE report 17743733 ↗
• MalfunctionAug 16, 2023Impedance Problem; Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE SHOWED AFFECTED CHANNELS. THE USER WAS IN THE EARTHQUAKE IN HATAY IN 2023 AND FELL DOWN SOME STAIRS WHILE ESCAPING. ABOUT 10-15 DAYS LATER THERE WAS NO MORE SOUND FROM THE IMPLANT ON THE LEFT SIDE. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 17555111 ↗
• MalfunctionJul 5, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE HUSBAND REPORTED THAT THE USER HAS NOT BEEN HAVING GOOD SPEECH COMPREHENSION FOR THE PAST 12-18 MONTHS.

  Patient problems: Failure of Implant

  MAUDE report 17256662 ↗
• MalfunctionFeb 6, 2023Impedance Problem; Impedance Problem

  A ROUTINE FITTING WAS PERFORMED ON (B)(6) 2023 WHERE AFFECTED CHANNELS WERE SEEN. THE PARENTS DID NOT NOTICE ANY HEARING DEFICIT ON THE LEFT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 16302895 ↗
• MalfunctionFeb 2, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED AFTER A HEAD TRAUMA OCCURRED IN (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 16282314 ↗
• MalfunctionJan 11, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AND CHANNELS WITH ABNORMAL IMPEDANCES HAVE BEEN OBSERVED. RE-IMPLANTATION IS CONSIDERED, HOWEVER A DATE FOR SURGERY HAS NOT BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 16136381 ↗
• MalfunctionOct 27, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  AROUND (B)(6) 2022, THE USER REPORTED THAT SHE COULD NO LONGER HEAR WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 15680257 ↗
• MalfunctionSep 9, 2022Migration; Migration

  THE USER REPORTED THAT RECENTLY THE IMPLANT HOUSING HAS MOVED DOWN TOWARDS THE PINNA. A REVISION SURGERY FOR AN IMPLANT BED IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 15388783 ↗
• MalfunctionSep 7, 2022Output Problem; Output Problem

  THE MOTHER REPORTED THAT THE USER COULD NO LONGER HEAR WITH THE DEVICE. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 15368162 ↗
• MalfunctionSep 7, 2022Output Problem; Output Problem

  THE USER REPORTED THAT HE COULD HARDLY HEAR WITH THE DEVICE. AN X-RAY WILL BE TAKEN. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 15368045 ↗

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. Mi100
• 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