Mi1200 SYNCHRONY +FLEX20 07880Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 09008737078805), received between Oct 12, 2018 and Nov 18, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Migration; Migration

  THE USER PRESENTED AT THE CLINIC WITH PERSISTENT COMPLAINTS SINCE (B)(6) 2020 AND NO HEARING IMPROVEMENT. DUE TO LACK OF BENEFIT, THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580641 ↗
• MalfunctionApr 30, 2024Impedance Problem; Lack of Effect; Impedance Problem; Lack of Effect

  THE USER EXPRESSED DISSATISFACTION WITH THE SOUND QUALITY DESPITE PROGRAMMING ADJUSTMENTS AND FELT THAT PROGRESS HAD REGRESSED. IN SITU TESTING SHOWED 2 AFFECTED CHANNELS. THE USER WAS RE-IMPLANTED ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 19212430 ↗
• MalfunctionFeb 23, 2022Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER STATED THAT SHE HAS NO AUDIO PERCEPTION WITH THE DEVICE ANYMORE. THE USER REPORTEDLY SUFFERED A TRAUMA. THE USER WAS REIMPLANTED ON THE (B)(6) 2022. REINSERTION ATTEMPTS WERE UNSUCCESSFUL THEREFORE THE CLINIC DECIDED TO IMPLANTED A NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 13585244 ↗
• InjuryAug 9, 2021Output Problem; Output Problem

  THE USER'S PERFORMANCE WITH THE DEVICE IS AFFECTED. IN SITU TESTING SHOWED AFFECTED CHANNELS. REIMPLANTATION WAS PERFORMED ON (B)(6) 2021. THIS REPORT REFERS TO 9710014-2021-0051. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 12292406 ↗
• InjuryJul 14, 2021Output Problem; Output Problem

  THE USER'S PERFORMANCE WITH THE DEVICE IS AFFECTED. REIMPLANTATION WAS PERFORMED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12166666 ↗
• InjuryJun 30, 2020Migration; Migration

  THE IMPLANT APPEARED TO HAVE MOVED AND THE CLINIC WAS CONCERNED ABOUT THE INTEGRITY OF THE SKIN FLAP. BOTH THE IMPLANT HOUSING AND ELECTRODE HAD MIGRATED. THE HOUSING WAS SITTING AGAINST THE POST AURICULAR SULCUS AND ONLY 2 ELECTRODES WERE INTRA-COCHLEAR. THE MAGNET STRENGTH WAS REPORTEDLY DEEMED APPROPRIATE FOR THE USER. THEREFORE, THE USER WAS RE-IMPLANTED WITH A NEW DEVICE. POST-OP CT THE NEXT DAY CONFIRMED FULL INSERTION.

  Patient problems: Failure of Implant; No Information

  MAUDE report 10211195 ↗
• InjuryJul 19, 2019Output Problem; Output Problem

  IN SITU MEASUREMENT SHOWED AFFECTED CHANNELS. ACCORDING TO THE PARENTS THE CHILD STOPPED BABBLING ABOUT A MONTH AGO. NO ACCIDENT OR TRAUMA WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8806188 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE RECIPIENT PRESENTED WITH ALTERED PITCH PERCEPTION AND PAIN WHEN STIMULATED WITH HIGH FREQUENCIES FIRST ON (B)(6) 2018. THE PROBLEM PERSISTED. STIMULATION LEVELS ON BASAL CONTACTS THAT WERE ACCEPTABLE AND NOT PAINFUL DID NOT LEAD TO A SATISFYING HEARING.

  Patient problems: Failure of Implant

  MAUDE report 7959718 ↗

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-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-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