Mi1250 SYNCHRONY 2 STANDARD S-Vector Magnet 39535Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 09008737395353), received between Jul 20, 2022 and Apr 20, 2026 — classified as 6 injuries, 11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Adverse Event Without Identified Device or Use Problem

  THE USER HAD AN INFECTION OVER THE IMPLANT AREA AFTER A MAGNET REVISION SURGERY. THE USER WAS EXPLANTED IN (B)(6) 2025 AND REIMPLANTED AT A LATER POINT IN (B)(6) 2026 AFTER HEALING PROCESS OF 3 MONTHS.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 24924637 ↗
• MalfunctionDec 22, 2025Impedance Problem; Impedance Problem

  SINCE (B)(6) 2025, 7-10 CHANNELS WOULD MOVE IN AND OUT OF HIGH IMPEDANCE STATUS. THREE CHANNELS HAVE BEEN DISABLED (B)(6) 2025. FURTHER STEPS ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23862916 ↗
• MalfunctionDec 19, 2025Electrical Shorting; Electrical Shorting

  DURING INTRAOPERATIVE MEASUREMENT, A SHORT CIRCUIT WAS DETECTED. THE BACKUP IMPLANT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848101 ↗
• MalfunctionDec 19, 2025Migration; Migration

  THE USER HAD INSUFFICIENT SPEECH COMPREHENSION. CT IMAGING REVEALED THE ELECTRODE ARRAY HAD PARTIALLY MIGRATED OUT OF THE COCHLEA. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847854 ↗
• MalfunctionDec 11, 2025Circuit Failure; Circuit Failure

  THE USER HAD AN ACCIDENT WITH A SWING AND IT CAUSED A FLUCTUATING SWELLING ABOVE THE IMPLANT. THE USER IS NOT ABLE TO HEAR. THE USER HAS BEEN REIMPLANTED.

  Patient problems: Head Injury

  MAUDE report 23776253 ↗
• MalfunctionOct 17, 2025Impedance Problem; Impedance Problem

  THE USER REPORTS WORSENING HEARING IMPRESSION AND SPEECH UNDERSTANDING. THE IMPLANT CHECK REVEALED THAT THE DEVICE IS NO LONGER FUNCTIONING ACCORDING TO SPECIFICATION. THE USER HAS BEEN REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321750 ↗
• MalfunctionAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE USER WAS IMPLANTED ON (B)(6) 2024. MAGNET RETENTION FORCE IS INSUFFICIENT DESPITE SKIN FLAP <5MM, S-VECTOR INTERNAL MAGNET AND 5S RONDO3 EXTERNAL MAGNET. THE PROBLEM REMAINS SINCE ACTIVATION. RELATIVE ORIENTATION OF INTERNAL AND EXTERNAL MAGNET HAS BEEN VERIFIED - MAGNET POLES ARE ALIGNED. INTERNAL MAGNET IS ALSO ROTATABLE. DIFFERENT EXTERNAL MAGNETS HAVE BEEN TESTED. THE USER WAS IMPLANTED ON (B)(6) 2024. MAGNET RETENTION FORCE IS INSUFFICIENT DESPITE SKIN FLAP <5MM, S-VECTOR INTERNAL MAGNET AND 5S RONDO3 EXTERNAL MAGNET. THE PROBLEM REMAINS SINCE ACTIVATION. RELATIVE ORIENTATION OF INTERNAL AND EXTERNAL MAGNET HAS BEEN VERIFIED - MAGNET POLES ARE ALIGNED. INTERNAL MAGNET IS ALSO ROTATABLE. DIFFERENT EXTERNAL MAGNETS HAVE BEEN TESTED.

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

  MAUDE report 22738861 ↗
• MalfunctionJul 2, 2025Mechanical Jam; Noise, Audible; Mechanical Jam; Noise, Audible

  IN (B)(6) 2025 THE USER NOTICED A WEAKENING OF THE MAGNET STRENGTH OF HIS PROCESSOR (RONDO 3) HOLDING OVER HIS IMPLANT. THE CLINIC HAS SCHEDULED A SURGERY TO CHANGE THE IMPLANT MAGNET ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22382855 ↗
• InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, A POINT OF SUTURE WAS INFECTED, AND THE TREATMENT DID NOT SOLVE THE ISSUE. THE USER HAS BEEN EXPLANTED.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 21633692 ↗
• MalfunctionFeb 21, 2025Migration; Migration

  IT WAS REPORTED THAT THE USER HAS NO HEARING RESPONSE ON THREE CHANNELS DURING SINGLE CHANNEL STIMULATION. CURRENTLY, 10 CHANNELS ARE USABLE FOR STIMULATION; HOWEVER, CHANNELS 7-9 ALSO SEEM UNUSABLE DUE TO NO RESPONSE REGARDLESS OF THE STIMULATION. IMPLANT CHECK WAS CONDUCTED ON (B)(6) 2024. DURING THE APPOINTMENT 6 CHANNELS WERE DEACTIVATED DUE TO INSUFFICIENT BENEFIT FROM THESE, WHICH RESULTED IN LIGHTLY BETTER SOUND QUALITY. A CT SCAN WAS PLANNED. THE USER HAS BEEN RE-IMPLANTED ON (B)(6) 2025 DUE TO A COMPLETE ELECTRODE MIGRATION OUT OF THE COCHLEA.

  Patient problems: Failure of Implant

  MAUDE report 21430700 ↗
• MalfunctionFeb 14, 2025Malposition of Device; Insufficient Device Problem Information; Malposition of Device; Insufficient Device Problem Information

  THE USER WAS IMPLANTED ON (B)(6) 2023 AND DID NOT HAVE A FIRST FITTING UNTIL (B)(6) 2025 DUE TO MEDICAL PROBLEMS. THE USER REPORTED UNPLEASANT PERCEPTION WITH USING THE DEVICE AND CANNOT WEAR THE AUDIO PROCESSOR. RE-IMPLANTATION OR RE-POSITIONING IS CONSIDERED.

  Patient problems: Failure of Implant; Tissue Breakdown

  MAUDE report 21382855 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER HAS BEEN EXPLANTED. A HEMATOMA HAS BEEN NOTED OVER THE IMPLANT SITE. REIMPLANTATION IS CONSIDERED IN 3 MONTHS.

  Patient problems: Unspecified Infection

  MAUDE report 21344595 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE DEVICE EXPLANT REPORT FORM THE USER HAD MENINGITIS. REPORTEDLY, THE USER CAME TO THE CLINIC WITH MENINGITIS ON (B)(6) 2024 AND GOT SURGERY ON THE SAME DAY. THE CI WAS LEFT IMPLANTED, ONLY THE ELECTRODES WERE REMOVED FROM THE COCHLEA. ACCORDING TO THE DOCUMENTATION OF THE HOSPITAL, THE USER PROBABLY REMAINED IN THE CLINIC UNTIL (B)(6) 2024 WITHOUT ANY COMPLICATIONS. ON (B)(6) 2024 CHECK-UP WAS DONE AT THE AMBULATORY CENTER. ON (B)(6) 2024 THE USER WAS RE-IMPLANTED WITH A NEW DEVICE.

  Patient problems: Meningitis

  MAUDE report 19545379 ↗
• MalfunctionOct 31, 2023Migration; Migration

  MIGRATION OF THE ELECTRODE WAS REPORTED. RE-POSITIONING OF THE ELECTRODE ARRAY IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 18038018 ↗
• InjuryJul 6, 2023Device Appears to Trigger Rejection; Microbial Contamination of Device; Device Appears to Trigger Rejection; Microbial Contamination of Device

  THE USER HAS BEEN EXPLANTED. FURTHER INFORMATION STATED THIS WAS DUE TO MEDICAL REASONS. THE REASON FOR EXPLANTATION WAS AN INFECTION IN THE IMPLANT AREA WITH AN EXPOSED COIL. IN ADDITION THERE WAS A BIOFILM ON THE IMPLANT. STAPHYLOCOCCUS AUREUS WAS VERIFIED. DURING EXPLANTATION, THE ACTIVE ELECTRODE WAS CUT OFF AND LEFT INSIDE THE COCHLEA. RE-IMPLANTATION OCCURRED AT A LATER POINT IN TIME.

  Patient problems: Bacterial Infection

  MAUDE report 17265324 ↗
• MalfunctionMay 12, 2023Impedance Problem; Impedance Problem

  REPORTEDLY THE USER HAD AN ACCIDENT IN (B)(6) 2023. AFFECTED CHANNELS WERE REPORTED. THE USER REPORTED GOOD BENEFIT FROM THE DEVICE BEFORE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 16917416 ↗
• InjuryJul 20, 2022Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTEDLY THE USER WAS EXPLANTED ON (B)(6).2022 DUE TO A CHRONIC INFLAMMATION AND A FISTULA FORMATION.

  Patient problems: Inflammation; Skin Inflammation/ Irritation

  MAUDE report 15063188 ↗

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