Mi1210 SYNCHRONY ST +FLEX26 36619Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09008737366193), received between Jun 29, 2021 and Sep 2, 2025 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Circuit Failure; Circuit Failure

  REPORTEDLY, COUPLING WAS POOR AND AUDIO PROCESSOR KEEP ON BLINKING RED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935970 ↗
• MalfunctionJul 17, 2025Impedance Problem; Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528019 ↗
• MalfunctionSep 26, 2023Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE REPORTED. RE-IMPLANTATION IS CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

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

  MAUDE report 17815742 ↗
• MalfunctionMay 30, 2023Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED THAT WHEN THE USER CAME TO THE CLINIC ON (B)(6), 2023 ADDITIONAL CHANNELS WITH ABNORMAL IMPEDANCES WERE FOUND. RE-IMPLANTATION IS PLANNED FOR (B)(6), 2023.

  Patient problems: Failure of Implant

  MAUDE report 17018671 ↗
• MalfunctionJan 3, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WAS SUDDENLY AFFECTED. DURING A REGULAR FOLLOW UP IN SITU MEASUREMENT HIGH CHANNELS WERE NOTICED.

  Patient problems: Failure of Implant

  MAUDE report 16084516 ↗
• MalfunctionAug 24, 2022Migration; Migration

  ON (B)(6) 2021 FAMILY REPORTED THE POSITION OF DEVICE HAS CHANGED FROM ABOVE TO UNDER THE HELIX PUSHING ON THE SKIN. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Discomfort; Failure of Implant; Swelling/ Edema

  MAUDE report 15283692 ↗
• MalfunctionAug 17, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AFTER IMPLANTATION THE USER FELT PAIN AT THE IMPLANT AREA. WHEN IT WAS INVESTIGATED, IT SEEMED THAT NO IMPLANT BED WAS DRILLED AND THERE WAS BUCKLING OF THE SKIN AT THE MAGNET SITE. AFTER THE REVISION, PAIN WAS TEMPORARILY GONE, BUT SOMETIME AFTER CAME BACK (AROUND SUMMER 2022). PAIN IS AT THE IMPLANT AREA AND THE USER IS NOT ABLE TO WEAR COIL OVER THE IMPLANT FOR A LONG TIME BECAUSE OF PAIN. A REVISION SURGERY WAS DONE IN NOVEMBER 2021 WHERE THE IMPLANT PLACE WAS CHANGED TO BE SYMMETRICAL WITH THE CONTRALATERAL IMPLANT SITE AND PROPER IMPLANT BED AND ATTACHMENT WERE DONE. A REVISION SURGERY IS PLANNED BUT NO DATE HAS BEEN PROVIDED YET.

  Patient problems: Implant Pain; Inflammation

  MAUDE report 15238470 ↗
• MalfunctionOct 5, 2021Migration; Migration

  ON 26SEP2021 THE FAMILY OF THE USER REPORTED THAT THE POSITION OF THE DEVICE HAS CHANGED AND NOW PROTRUDES MORE OUTWARDS. THE FAMILY IS NOT ABLE TO VISIT THE CLINIC DUE TO THE PANDEMIC AND LOCKDOWN. REVISION SURGERY MAY BE CONSIDERED WHEN THE LOCKDOWN IS REMOVED.

  Patient problems: Insufficient Information

  MAUDE report 12575443 ↗
• InjuryJun 29, 2021Output Problem; Output Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IT WAS REPORTED THAT A A SUDDEN LOSS OF HEARING WAS EXPERIENCED. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12082919 ↗

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