Mi1200 SYNCHRONY +FLEX26 36617Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 09008737366179), received between May 14, 2021 and Nov 20, 2025 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. FURTHER PROCEEDINGS ARE CURRENTLY UNKNOWN. THE CLINIC WILL PERFORM X-RAY IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605825 ↗
• MalfunctionSep 19, 2025Migration; Migration

  DURING MAPPING IN (B)(6) 2025 ONLY LIMITED RESPONSES WERE OBSERVED AND THE USER REPORTED DIZZINESS UPON INCREASING THE STIMULATION LEVELS.

  Patient problems: Dizziness

  MAUDE report 23097094 ↗
• MalfunctionDec 3, 2024Impedance Problem; Impedance Problem

  THE USER REPORTED A GRADUAL DECLINE IN HEARING PERFORMANCE WITH THE DEVICE. THE USER WAS EXPLANTED ON (B)(6) 2024.

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

  MAUDE report 20832962 ↗
• MalfunctionSep 2, 2024Impedance Problem; Impedance Problem

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

  Patient problems: Failure of Implant

  MAUDE report 20118065 ↗
• MalfunctionAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER_S REHABILITATION PROGRESS IS NOT MEETING EXPECTATIONS. THE USER WAS RE-IMPLANTED ON (B)(6) 2024. REPORTEDLY, THE REASON FOR EXPLANTATION WAS PAIN, WHICH WAS PRESENT WHEN THE DEVICE WAS USED, EVEN WITH LOW QU LEVELS.

  Patient problems: Pain

  MAUDE report 19979451 ↗
• MalfunctionJul 24, 2024Impedance Problem; Impedance Problem

  THE HEARING PERFORMANCE WITH THE LEFT-SIDED DEVICE IS AFFECTED. TRAUMA WAS REPORTED. THERE WAS NO SWELLING OR REDNESS AROUND THE IMPLANT AREA. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19814913 ↗
• MalfunctionOct 3, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA TO THE LEFT SIDE OF THE HEAD. THE USER'S PARENTS ALSO REPORTED REDNESS AT THE SIDE OF THE IMPLANT. REIMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 17859888 ↗
• MalfunctionAug 21, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED AFTER A TRAUMA TO THE HEAD. THE USER HAS COCHLEAR ANAPLASIA. RE-IMPLANTATION IS BEING CONSIDERED.

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

  MAUDE report 17585528 ↗
• MalfunctionMay 30, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER'S MOTHER NOTICED A CHANGE IN HEARING WITH THE DEVICE AFTER TRAUMA TO THE HEAD. CT IMAGING WILL BE PERFORMED AND REIMPLANTATION SURGERY IS BEING CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 14539632 ↗
• InjurySep 8, 2021Output Problem; Output Problem

  DURING THE FIRST MAPPING HIGH IMPEDANCES WERE SEEN ON MULTIPLE CHANNELS, THEREFORE THE CLINIC DECIDED TO REIMPLANT THE USER. REPORTEDLY, NO PROBLEMS WERE ENCOUNTERED DURING IMPLANTATION SURGERY. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12438043 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER HAD A CHRONIC INFECTION IN THE BLIND SAC CLOSURE SITE. THE USER WAS EXPLANTED ON (B)(6) 2021 AND IT IS PLANNED TO RE-IMPLANT AT A LATER DATE.

  Patient problems: Bacterial Infection

  MAUDE report 11824216 ↗

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