Mi1250 SYNCHRONY 2 FLEXsoft S-Vector Magnet 39541Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 09008737395414), received between Dec 15, 2020 and Sep 25, 2026 — classified as 14 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Migration” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Apr 18, 2024Class IIOpen, Classified

   A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

   Z-2356-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Impedance Problem

  The user's hearing performance is affected. During the fitting session the IFT showed 7 channels in Hi impedance. The user will go back to the clinic to have a second check.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50895636 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  Due to a wound-healing complication, it was decided to remove the implant housing. A new implant will be inserted after the healing phase.

  Patient problems: Post Operative Wound Infection

  MAUDE report 50447104 ↗
• MalfunctionJun 12, 2026Migration

  POST-OP IMAGING TAKEN ON THE DAY OF IMPLANTATION PRIOR TO DISCHARGE SHOWED ONLY 5 CHANNELS STILL IN THE COCHLEA. THIS ARRAY WAS REPOSITIONED ON (B)(6), BY THE IMPLANTING SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25483751 ↗
• MalfunctionJun 9, 2026Circuit Failure; No Device Output

  CONNECTION TO THE IMPLANT CANNOT BE ESTABLISHED AFTER USER SUSTAINED A TEMPORAL BONE FRACTURE. THE USER WAS REIMPLANTED.

  Patient problems: Head Injury

  MAUDE report 25439540 ↗
• InjuryMar 4, 2026Device Appears to Trigger Rejection; Improper or Incorrect Procedure or Method

  THE DEVICE HAS BEEN EXPLANTED. THE USER HAS BEEN REIMPLANTED WITH A NEW DEVICE. REPORTEDLY, DURING AN EAR CLEANING THE ELECTRODE ARRAY WAS PULLED OUT OF THE COCHLEA AND WAS DISLOCATED IN THE EAR CANAL. THE USER THEN COULD NO LONGER HEAR WITH THE CI.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Tears

  MAUDE report 24506239 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  THE USER WAS EXPLANTED ON (B)(6) 2026 DUE TO INFLAMMATION OF THE CAVITY.

  Patient problems: Inflammation

  MAUDE report 24468263 ↗
• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS EXPLANTED DUE TO POOR SCAR HEALING AND POST-OPERATIVE DEHISCENCE WITH INFECTION.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 23920574 ↗
• MalfunctionNov 25, 2025Migration; Migration

  THE USER HAS REPORTED THAT THE SOUND QUALITY HAS DECREASED AND IS EXPERIENCING FACIAL NERVE STIMULATION. THE USER HAS BEEN REIMPLANTED.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 23645886 ↗
• InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS AN INFECTION SURROUNDING THE IMPLANT. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 23496145 ↗
• MalfunctionOct 30, 2025Migration; Migration

  THE USER REPORTED POOR SOUND QUALITY. REINSERTION IS PLANNED FOR (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423556 ↗
• MalfunctionOct 21, 2025Impedance Problem; Impedance Problem

  THE USER HAD A FALL. IT IS UNCERTAIN IF HE HIT HIS HEAD. HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED SINCE THEN.

  Patient problems: Head Injury

  MAUDE report 23346341 ↗
• MalfunctionOct 21, 2025Migration; Migration

  DUE TO A MIGRATION OF THE IMPLANT HOUSING A REVISION SURGERY TOOK PLACE IN WHICH THE IMPLANT WAS RE-POSITIONED. SINCE REPOSITION SURGERY THE USER HAS NO SOUND PERCEPTION ON THE MOST BASAL CHANNEL, WHICH WAS SUBSEQUENTLY DEACTIVATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23345420 ↗
• MalfunctionSep 19, 2025Impedance Problem; Impedance Problem

  DURING THE FITTING SESSION, AFFECTED CHANNELS WERE FOUND. THERE IS A DECREASE IN THE USER_S PERCEPTION. THE USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095584 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CSF WAS LEAKING OUT OF THE COCHLEA.

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 23013692 ↗
• InjuryAug 21, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER HAS BEEN EXPLANTED DUE TO AN EXTRUSION OF THE IMPLANT.

  Patient problems: Skin Tears

  MAUDE report 22858299 ↗
• MalfunctionJul 7, 2025Migration; Migration

  THE USER HAS NO AUDITORY IMPRESSION. THE USER HAS BEEN REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22411926 ↗
• MalfunctionApr 30, 2025Impedance Problem; Impedance Problem

  THE USER HAS HAD GOOD PERFORMANCE WITH THE IMPLANT, HOWEVER HE DOES NOTICE A PINGING SOUND WITH STIMULATION. THE USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21932651 ↗
• MalfunctionApr 24, 2025Impedance Problem; Impedance Problem

  THE USER HAD AN EPILEPTIC SEIZURE AND FELL ON HER HEAD. SHE THEN HAD A DIFFERENT AUDITORY IMPRESSION. THE USER WAS RE-IMPLANTED ON (B)(6) 2025.

  Patient problems: Head Injury

  MAUDE report 21897090 ↗
• MalfunctionApr 23, 2025Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WAS PROGRESSING WELL WITH THE IMPLANT BUT APPROXIMATELY 4 WEEKS AGO (ON (B)(6) 2025) A SCRATCHY SOUND AND ECHO WAS REPORTED. THE USER HAD REVISION SURGERY ON (B)(6) 2025 TO REINSERT THE IMPLANT. THE SURGEON OBSERVED ELECTRODES OUTSIDE OF THE COCHLEA. HE WAS ABLE TO REINSERT THE DEVICE WITHOUT ANY ISSUES.

  Patient problems: Discomfort

  MAUDE report 21887747 ↗
• MalfunctionMar 28, 2025Impedance Problem; Impedance Problem

  ON (B)(6) 2025, THE USER WAS ADMITTED TO THE EMERGENCY ROOM AS HE BLEW HIS NOSE AND FORCED AIR UP UNDER HIS FLAP. THE USER IS 5 DAYS POST CI SURGERY. HE REPORTED PAIN IMMEDIATELY AFTER DOING THIS. AT INITIAL ACTIVATION ON (B)(6) 2025, THE USER REPORTED VARIOUS_ FEELING_ SENSATIONS, BUT LEFT THE SESSION BEING ABLE TO HEAR SOUND WITH THE DEVICE. THE USER WAS SEEN AGAIN ON (B)(6) 2025 FOR FOLLOW UP. INITIALLY HE STATED THAT IT FELT LIKE A "9 VOLT BATTERY" IN HIS HEAD WHICH IS WHY HE HAD NOT BEEN WEARING THE DEVICE. RE-MAPPING AS DONE, CHANNELS WERE DEACTIVATED AND HE REPORTED IMPROVEMENT. HE WILL BE SEEN AGAIN FOR FOLLOW-UP.

  Patient problems: Pain

  MAUDE report 21717395 ↗
• MalfunctionMar 20, 2025Impedance Problem; Impedance Problem

  DURING SURGERY, THE SURGEON ENCOUNTERED UNEXPECTED FIBROSIS, AND IT WAS NOT POSSIBLE TO ACHIEVE FULL INSERTION (CHANNELS 11 AND 12 WERE EXTRA-COCHLEAR). THE SURGEON DECIDED TO REPLACE THE IMPLANT WITH A SHORTER ELECTRODE ARRAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649998 ↗
• MalfunctionMar 3, 2025Improper or Incorrect Procedure or Method; Impedance Problem; Improper or Incorrect Procedure or Method; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. DUE TO THE IMPLANT POSITION THE COIL TOUCHED THE PROCESSOR. IN ORDER TO FIX THIS ISSUE, THE CLINIC PERFORMED A REPOSITION OF THE IMPLANT TWO WEEKS AGO. DURING/AFTER THE SURGERY THE ELECTRODE MIGRATED AND CHANNELS 11 AND 12 ARE NOW OUTSIDE OF THE COCHLEA AS CONFIRMED BY X-RAY). AN IMPLANT CHECK IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 21504597 ↗
• MalfunctionFeb 21, 2025Circuit Failure; Circuit Failure

  DURING A FITTING SESSION, IT WAS NOT POSSIBLE TO RUN THE IN-SITU MEASUREMENTS BECAUSE OF AN ERROR MESSAGE FROM THE MAESTRO SOFTWARE SAYING THAT THE DEVICE WAS NOT DETECTED. THE AUDIO PROCESSOR'S DL-COIL, THE MAX S-COIL AND THE COUPLING CHECK TOOL WERE TRIED. A DIFFERENT MAX AND A DIFFERENT LAPTOP WERE ALSO TRIED, BUT THE RESULT WAS STILL THE SAME. THE EXTERNAL PART WAS CHECKED, AND EVERYTHING WAS WORKING. THE USER DOES NOT HAVE HEARING SENSATION ON THE CONCERNED LEFT SIDE, AS ALSO CONFIRMED BY THE AUDIOMETRIC TEST. REIMPLANTATION IS CONSIDERED BUT NOT DATE HAS BEEN SCHEDULED AS YET.

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

  MAUDE report 21430524 ↗
• InjuryFeb 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER HAS BEEN EXPLANTED DUE TO AN INFECTION IN THE MASTOID BOWL. THE SURGEON OPTED TO REMOVE THE INFECTION AND THE IMPLANT TO REDUCE POSSIBILITY OF FURTHER INFECTION, AND NOT TO REIMPLANT THE USER UNTIL THE INFECTION WAS TAKEN CARE OF. THE SURGEON REPORTED INFECTION WAS CONFIRMED BY CULTURES, WHEN MEETING WITH THE SURGEON HE WAS UNSURE WHAT THE RESULT WAS. THE INFECTION BEGAN A FEW WEEKS PRIOR TO THE EXPLANTATION AND THE PATIENT UNDERWENT ANTIBIOTICS TO TRY AND TREAT THE INFECTION.

  Patient problems: Mastoiditis

  MAUDE report 21382971 ↗
• InjuryJan 15, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  WOUND DEHISCENCE RETRO AURICULAR STATUS POST COCHLEA-IMPLANTATION. EXPLANTATION DUE TO SKIN DEFECT OVER THE IMPLANT. DEVICE WAS EXTRUDED RETROAURICULLARY, CABLE WAS EXTRUDED IN THE CAVITY. A RETROAURICULAR INFECTION WAS CAUSED BY THE EXTRUSION. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Skin Tears

  MAUDE report 21157302 ↗

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-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
• 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