Mi1250 SYNCHRONY 2 FLEXsoft 36678Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 09008737366780), received between Nov 30, 2020 and Apr 13, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Output Problem” (5 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.

• MalfunctionApr 13, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE DECREASED. FURTHER PROCEEDING IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854170 ↗
• MalfunctionDec 6, 2023Impedance Problem; Impedance Problem

  IT WAS INITIALLY REPORTED THAT IN SITU MEASUREMENTS RECEIVED SHOW SEVERAL CHANNELS WITH HIGH IMPEDANCE AND A HIGH GPI. IT IS NOT REALLY POSSIBLE TO EVALUATE THE HEARING PERCEPTION OF THE USER AS HE CANNOT COMMUNICATE THIS HIMSELF. PRESSURE OVER THE REFERENCE ELECTRODE AREA HAS BEEN APPLIED DURING TELEMETRY, TO EXCLUDE ANY AIR BUBBLE. NO TRAUMA WAS REPORTED BY CLINICIANS AND /OR PARENTS. RE-IMPLANTATION OCCURRED (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18273026 ↗
• MalfunctionOct 30, 2023Migration; Migration

  THE RECIPIENT HAS 3 EXTRACOCHLEAR CHANNELS IDENTIFIED FROM POST-OP OTOPLAN REPORT (IMAGING). THE USER WOULD LIKE TO HAVE BETTER FREQUENCY ALLOCATION. POTENTIAL RE-INSERTION OF ELECTRODE OR NEW IMPLANT SURGERY IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 18029449 ↗
• MalfunctionOct 29, 2021Output Problem; Output Problem

  THE USER FELL HITTING HIS HEAD ON THE FLOOR DIRECTLY OVER THE IMPLANT SITE. THE FALL OCCURRED AROUND THE BEGINNING OF (B)(6) 2021, AFTER WHICH THERE WAS SWELLING AND A BUMP/SWOLLEN AREA OVER THE LEFT IMPLANT SITE. THE USER WAS TO BE RE-IMPLANTED ON THE (B)(6) 2022, HOWEVER, THE SURGERY WAS CANCELLED DUE TO COVID. NO NEW DATE HAS BEEN SET YET.

  Patient problems: Failure of Implant

  MAUDE report 12717485 ↗
• InjuryAug 20, 2021Output Problem; Output Problem

  IN SITU TESTING OF THE DEVICE SHOWED FLUCTUATING IMPEDANCES. IT WAS UNCLEAR IF THE PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER HAS HAD SMALL HEAD INJURIES IN THE PAST, BUT NONE THAT ARE KNOWN TO HAVE OCCURRED DURING THE CHANGE IN IMPEDANCES. THE USER HAS BEEN RE-IMPLANTED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12347088 ↗
• InjuryJun 23, 2021Output Problem; Output Problem

  THE CLINIC REPORTED THAT IN SITU TESTING OF THE DEVICE SHOWS FLUCTUATING IMPEDANCES. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12047843 ↗
• InjuryFeb 10, 2021Output Problem; Output Problem

  ALL CHANNELS ARE AFFECTED BY HIGH IMPEDANCE. IT IS UNKNOWN IF THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. HOWEVER, THE USER IS 19 MONTHS OLD AND GLOBALLY DELAYED, SO IT WAS NOT NOTICEABLE WHETHER THE RESPONSE TO SOUND CHANGED. THE USER WAS RE-IMPLANTED WITH A SHORTER ELECTRODE TYPE DUE TO A COCHLEAR MALFORMATION ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11306298 ↗
• InjuryNov 30, 2020Output Problem; Output Problem

  ALL CHANNELS ARE AFFECTED BY HIGH IMPEDANCE.

  Patient problems: Failure of Implant

  MAUDE report 10918780 ↗

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