Mi1250 SYNCHRONY 2 COMPRESSED S-Vector Magnet 39539Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09008737395391), received between Feb 12, 2024 and Sep 21, 2026 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem

  Explanted due to meningitis.

  Patient problems: Meningitis

  MAUDE report 50840316 ↗
• InjuryApr 27, 2026Device Appears to Trigger Rejection

  EXTRUSION OF THE IMPLANT HOUSING WAS REPORTED. THE USER WAS EXPLANTED.

  Patient problems: Tissue Breakdown

  MAUDE report 24996606 ↗
• MalfunctionDec 19, 2025Electrical Shorting; Impedance Problem; Electrical Shorting; Impedance Problem

  DURING FITTING ON (B)(6) 2025 IT WAS POSSIBLE TO IMPROVE THE USER'S SATISFACTION BUT HEARING PERFORMANCE IS STILL LIMITED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848097 ↗
• MalfunctionNov 25, 2025Impedance Problem; Migration; Impedance Problem; Migration

  THE USER WAS DOING WELL FOLLOWING INITIAL IMPLANTATION PER AUDIOLOGIST AND PARENT REPORT. FACIAL NERVE STIMULATION WAS PRESENT WHEN USING HER NEW MAPS WITH CHARGE UNITS ABOVE 15. THE USER UNDERWENT REIMPLANTATION SURGERY ON (B)(6) 2026. 5 CHANNELS WERE FOUND EXTRA-COCHLEAR.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 23646623 ↗
• InjuryNov 6, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE IMPLANT HOUSING IS EXTRUDING, THUS THE DEVICE WAS EXPLANTED. A RE-IMPLANTATION IS PLANNED WHEN THE WOUND IS HEALED.

  Patient problems: Skin Tears; Tissue Breakdown

  MAUDE report 23484637 ↗
• MalfunctionFeb 12, 2024Migration; Migration

  THE USER_S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. DURING THE REVISION SURGERY ON (B)(6) 2024 ONLY 4 CHANNELS WERE FOUND INSIDE THE COCHLEA. THE REINSERTION OF THE ELECTRODE WAS DIFFICULT DUE TO FIBROSIS INSIDE THE ROUND WINDOW. AFTER SEVERAL INSERTION ATTEMPTS THE ELECTRODE ARRAY SEEMED TO GET BENT AND IT WAS THEREFORE DECIDED TO REIMPLANT A NEW DEVICE. A FULL INSERTION WAS ACHIEVED.

  Patient problems: Failure of Implant

  MAUDE report 18684279 ↗

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-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
• 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. Mi100