Mi1250 SYNCHRONY 2 PIN FLEX24 S-Vector Magnet 39542Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 09008737395421), received between Aug 29, 2022 and Sep 21, 2026 — classified as 2 injuries, 4 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 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.

• MalfunctionSep 21, 2026Migration

  Hearing performance with the device is affected. Non auditory perception is present on basal electrodes.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50840299 ↗
• MalfunctionJul 2, 2026Migration

  THE DEVICE WAS EXPLANTED DUE TO ELECTRODE MIGRATION.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25687301 ↗
• MalfunctionNov 15, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER WAS RE-IMPLANTED IN AUGUST 2022, AND AT ACTIVATION ON (B)(6) 2022 IN SITU TESTING SHOWED ALTERED RESULTS.

  Patient problems: Failure of Implant

  MAUDE report 15796055 ↗
• InjurySep 23, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER SUFFERED FROM AN MRSA CELLULITIS INFECTION OVER THE IMPLANT HOUSING. DESPITE ANTIBIOTIC TREATMENT THERE WAS THEN AROUND 4MM OF EXTRUSION ALONG THE INTERIOR SIDE OF THE IMPLANT HOUSING. REPORTEDLY THE ELECTRODE WAS ALSO VISIBLE ALONG THE POSTERIOR ASPECT OF THE MASTOID CAVITY. AN EXPLANT KIT WAS REQUESTED AND THE DEVICE WAS EXPLANTED ON THE (B)(6) 2022. FURTHER INFORMATION HAS BEEN REQUESTED.

  Patient problems: Bacterial Infection

  MAUDE report 15474572 ↗
• InjurySep 20, 2022Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  THE USER SUFFERED FROM AN MRSA CELLULITIS INFECTION OVER THE IMPLANT HOUSING. DESPITE ANTIBIOTIC TREATMENT THERE WAS THEN AROUND 4MM OF EXTRUSION ALONG THE INTERIOR SIDE OF THE IMPLANT HOUSING. REPORTEDLY THE ELECTRODE WAS ALSO VISIBLE ALONG THE POSTERIOR ASPECT OF THE MASTOID CAVITY. THE MASTOID CAVITY APPEARED TO BE HEALTHY WITH NO EVIDENCE OF INFECTION. AN EXPLANT KIT WAS REQUESTED AND THE DEVICE WAS EXPLANTED ON THE (B)(6) 2022.

  Patient problems: Bacterial Infection

  MAUDE report 15452931 ↗
• MalfunctionAug 29, 2022Migration; Migration

  DURING POST-OP CT IMAGING 5 EXTRA-COCHLEAR CHANNELS WERE SEEN AND NOTED 2 MONTHS AFTER THE INITIAL IMPLANTATION. SURGEON REPORTED THAT THE ELECTRODES HAD EXTRUDED. THE USER WAS REIMPLANTED WITH A FLEX28 ELECTRODE VARIANT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310667 ↗

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