Mi1250 SYNCHRONY 2 PIN FLEXsoft S-Vector Magnet 39540Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 09008737395407), received between Mar 28, 2022 and Sep 16, 2026 — classified as 4 injuries, 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  The user has been explanted because of infection.

  Patient problems: Unspecified Infection

  MAUDE report 50784366 ↗
• MalfunctionJun 1, 2026Migration

  REDUCED PERFORMANCE WAS REPORTED. TWO CHANNELS WERE LEFT EXTRA-COCHLEAR AT IMPLANTATION. DESPITE REFITTING AND AURAL REHABILITATION, THERE HAS BEEN NO IMPROVEMENT. RE-INSERTION IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25346246 ↗
• MalfunctionApr 14, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874029 ↗
• InjuryFeb 6, 2026Device Appears to Trigger Rejection

  THE USER WAS EXPLANTED DUE TO POST-AURICULAR SKIN BREAKDOWN WITH PARTIAL IMPLANT EXTRUSION.

  Patient problems: Skin Tears; Tissue Breakdown

  MAUDE report 24276631 ↗
• InjuryJan 19, 2026Adverse Event Without Identified Device or Use Problem

  THE USER DEVELOPED A WOUND INFECTION 2 WEEKS AFTER THE INITIAL IMPLANTATION SURGERY ON (B)(6) 2025. THE INFECTION WORSENED SO THAT AN EXPLANTATION WAS PERFORMED. THE DEVICE WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24108433 ↗
• MalfunctionAug 27, 2025Migration; Migration

  THE DEVICE HAD TO BE REVISED DUE TO A DISLOCATION OF THE IMPLANT. THE DEVICE WAS REPOSITIONED ON (B)(6) 2025. THE REPOSITIONING PROCEDURE WAS DONE WITHOUT TOUCHING THE ELECTRODE; HOWEVER, THE NEXT CT-SCAN CHECK REVEALED THAT THE ELECTRODE MIGRATED OUT OF THE COCHLEA, WITH SHOWING ONLY 3 OR 4 CHANNELS IN THE BASAL PART OF THE COCHLEA. IT WAS THEREFORE DECIDED TO REOPEN THE SUTURES ON THE SAME DAY, TO REINSERT THE ELECTRODE. ONCE THE ELECTRODE WAS LOCATED, IT WAS DECIDED TO EXPLANT THE DEVICE. AFTER EXPLANTATION, DAMAGE TO THE ELECTRODE WAS OBSERVED. THE DEVICE SHOWED FOUR CHANNELS, AND THE FRONT PART OF THE ELECTRODE HAD DISAPPEARED AND COULD NO LONGER BE FOUND. THE USER WAS RE-IMPLANTED.

  Patient problems: Discomfort

  MAUDE report 22901846 ↗
• MalfunctionMar 17, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. NO TRAUMA HAS BEEN REPORTED. THE USER HAS BEEN RE-IMPLANTED.

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

  MAUDE report 21627483 ↗
• InjuryFeb 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER SUFFERED FROM AN INFECTION AND AN EXPOSED IMPLANT. IT WAS DECIDED TO EXPLANT THE DEVICE. THIS REPORT REFERS TO 9710014-2025-00101. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Tissue Breakdown

  MAUDE report 21310110 ↗
• MalfunctionJan 23, 2025Impedance Problem; Impedance Problem

  THE USER SHOWED A HIGH GROUND PATH IMPEDANCE (GPI) BEGINNING IN AUG-2024 AFTER EXPERIENCING A TRAUMA AT THE IMPLANT SITE. THE USER WAS REIMPLANTED.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 21217807 ↗
• MalfunctionMar 28, 2022Circuit Failure; Output Problem; Circuit Failure; Output Problem

  THE USER BEGAN EXHIBITING CONCERNS WITH RIGHT IMPLANT ABOUT 2 WEEKS AGO (B)(6) 2022). FIRST, THE USER THREW AND BROKE THE PRIMARY PROCESSOR, SO THE FAMILY STARTED USING THE BACK UP PROCESSOR. IT WORKED FINE FOR A COUPLE OF DAYS, THEN THE DL-COIL BEGAN INTERMITTENTLY FLASHING RED WHILE ON THE HEAD, WHICH THEN BECAME A CONSTANT RED FLASH. MOTHER REPORTEDLY REPLACED ALL EXTERNAL COMPONENTS, BUT THE DL-COIL FLASHING PERSISTED. SINCE THE CHILD WAS EXHIBITING NO SIGNS OF HEARING FROM THE IMPLANT THEY DISCONTINUED USE OF THE PROCESSOR ON THAT SIDE.

  Patient problems: Failure of Implant

  MAUDE report 13928058 ↗

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-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-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-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