Mi1250 SYNCHRONY 2 MEDIUM 36674Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 09008737366742), received between May 6, 2021 and Sep 24, 2026 — classified as 1 death, 4 injuries, 4 malfunctions.

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

• DeathSep 24, 2026Insufficient Device Problem Information

  The recipient was implanted on (b)(6) 2026. Approximately 3 weeks post-OP, she developed meningitis. She was hospitalized and died within a few days.

  Patient problems: Meningitis

  MAUDE report 50883832 ↗
• InjuryNov 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER IS UNABLE TO WEAR THE EXTERNAL DEVICE DUE TO SWELLING CAUSED BY INFLAMMATION AROUND THE IMPLANT AREA. THE USER HAS BEEN REIMPLANTED.

  Patient problems: Swelling/ Edema

  MAUDE report 23591413 ↗
• InjuryMay 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTEDLY, THE USER HAD AN INFECTION AND EXTRUSION OF THE IMPLANT. THE USER WAS EXPLANTED AND WILL BE RE-IMPLANTED AS SOON AS AN IMPLANT IS AVAILABLE.

  Patient problems: Skin Tears

  MAUDE report 21947820 ↗
• MalfunctionSep 30, 2024Impedance Problem; Impedance Problem

  IN SITU TESTING SHOWED AFFECTED CHANNELS. THE USER WAS REIMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20331551 ↗
• MalfunctionAug 29, 2024Migration; Migration

  THE CLINIC REPORTS THAT THE REASON FOR EXPLANTATION IS DUE TO A MASTOID ABSCESS WHICH THE IMPLANT HAD SLIPPED DOWN INTO.

  Patient problems: Tissue Breakdown

  MAUDE report 20094701 ↗
• MalfunctionJun 7, 2024Impedance Problem; Adverse Event Without Identified Device or Use Problem; Impedance Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE USER UNDERWENT REVISION A FEW DAYS AFTER IMPLANTATION DUE TO CSF LEAKAGE TO CLOSE THE SEALING. A HEMATOMA WAS PRESENT AS WELL. DURING THE REVISION SURGERY, THE ELECTRODE ARRAY WAS FOUND OUTSIDE THE COCHLEA. REIMPLANTATION WITH A FORM ELECTRODE IS BEING CONSIDERED DUE TO POSSIBLE DAMAGE TO THE ACTIVE ELECTRODE.

  Patient problems: Cerebrospinal Fluid Leakage; Failure of Implant

  MAUDE report 19489457 ↗
• InjuryOct 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  SKIN PROBLEMS APPEARED 6 DAYS POST IMPLANTATION (REDNESS). THE ENTS TREATED THE SKIN AND HEALING IMPROVED GRADUALLY. BUT IN (B)(6) 2023 THE PARENTS CAME TO THE CLINIC AND THE ENTS NOTED THAT THE IMPLANT HAD EXTRUDED. EXPLANTATION WILL BE PLANNED.

  Patient problems: Skin Tears

  MAUDE report 18038017 ↗
• MalfunctionApr 24, 2023Impedance Problem; Impedance Problem

  THE PARENTS REPORTED A DECREASE IN THE CHILD'S HEARING BENEFIT WITH THE DEVICE. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 16793839 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER SUFFERED FROM AN INFECTION. IN (B)(6) 2021 AN INFECTION OF THE MASTOID STARTED AND SOME PURULENT FLUID CAME OUT OF THE WOUND FROM THE COCHLEAR IMPLANT SURGERY. THE INFECTION WAS DETERMINED TO BE A STAPHYLOCOCCUS INFECTION, AS CONFIRMED BY BACTERIOLOGICAL EXAMINATION. THE RECIPIENT WAS TREATED WITH ANTIBIOTICS, BUT THE INFECTION RETURNED ON ABOUT (B)(6) 2021. THE MASTOID AND SKIN FLAP WERE AFFECTED BY THE INFECTION. THE USER WAS EXPLANTED ON THE CONCERNED LEFT SIDE ON THE (B)(6) 2021 AND WAS IMPLANTED ON THE CONTRA-LATERAL SIDE DURING THE SAME SURGERY.

  Patient problems: Bacterial Infection; Insufficient Information

  MAUDE report 11782520 ↗

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