Mi1250 SYNCHRONY 2 FLEX26 S-Vector Magnet 39547Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 09008737395476), received between Sep 1, 2021 and Sep 15, 2026 — classified as 8 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (13 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 34 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  The device has been explanted because of wound infection. Due to wound dehiscence and very thin skin coverage, the implant body was visible. Therefore, revision of the implant bed was indicated. The electrode was left in situ.

  Patient problems: Wound Dehiscence

  MAUDE report 50769721 ↗
• InjuryAug 12, 2026Device Appears to Trigger Rejection

  The user has been wearing her processor 24 hours a day for weeks on end and has developed an infection that has caused the implant to extrude. This report refers to 9710014-2026-00748. For further information please refer to this report.

  Patient problems: Tissue Breakdown

  MAUDE report 50218817 ↗
• InjuryJul 16, 2026Impedance Problem

  IT HAS BEEN REPORTED A HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. CHANNELS 1 TO 4 SHOWED HIGH IMPEDANCE AND WERE THEREFORE DEACTIVATED ON (b)(6) 2026. EXPERT MEASUREMENTS IN CONTINUOUS MODE SHOWED FLUCTUATING IMPEDANCE VALUES ON CHANNELS 1, 6, 7, 11. REIMPLANTATION CONSIDERED BUT NO TIME FRAME HAS BEEN SET YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25836950 ↗
• MalfunctionJun 26, 2026Migration

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25632751 ↗
• MalfunctionApr 10, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE HAS BEEN AFFECTED. THE USER HAS BEEN REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842529 ↗
• MalfunctionMar 24, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER FALLING OUT OF THE BED. THE CLINIC WILL SCHEDULE A DATE FOR REVISION SURGERY.

  Patient problems: Head Injury

  MAUDE report 24672161 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  THE USER SUFFERED A SKIN INFECTION NEAR THE IMPLANT AREA AND SKIN FLAP NECROSIS. DEVICE WAS EXPLANTED.

  Patient problems: Skin Infection

  MAUDE report 24559402 ↗
• MalfunctionMar 6, 2026Migration

  TWO ELECTRODE CHANNELS MIGRATED OUT OF COCHLEA AFTER IMPLANTATION. REVISION SURGERY WAS PERFORMED ON (B)(6) 2026 AND THE USER WAS IMPLANTED WITH A NEW DEVICE. AT EXPLANTATION 6 ELECTRODE CHANNELS WERE FOUND EXTRA-COCHLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24529271 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EXPLANTATION ON (B)(6) 2025 DUE TO GRANULATIONS IN THE AREA OF THE IMPLANT BEARING THAT LED TO SWELLING AND PAIN ABOVE THE IMPLANT. REIMPLANTATION IS PLANNED BUT NOT SCHEDULED YET.

  Patient problems: Granuloma

  MAUDE report 23645883 ↗
• MalfunctionOct 24, 2025Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER HAS BEEN REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23376914 ↗
• MalfunctionAug 21, 2025Impedance Problem; Impedance Problem

  THE USER UNDERWENT RE-IMPLANTATION SURGERY. IN SITU MEASUREMENTS REPORTEDLY SHOWED ONE CHANNEL WITH HIGH IMPEDANCE; THEREFORE, A BACK UP DEVICE WAS IMPLANTED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860234 ↗
• MalfunctionJul 9, 2025Migration; Migration

  REPORTEDLY THERE WAS A DECREASE IN PERFORMANCE AND INCREASINGLY HIGHER IMPEDANCE VALUES. INITIALLY THE USER HAD BENEFIT, BUT HAS SEEN A GRADUAL DECREASE IN PERFORMANCE SOON AFTER THEIR FOLLOW UP FROM ACTIVATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22457548 ↗
• InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER HAD AN INFECTION AT THE IMPLANT AREA. USER WAS EXPLANTED ON THE LEFT SIDE.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 22112506 ↗
• MalfunctionMay 15, 2025Impedance Problem; Impedance Problem

  THE SURGEON ELECTED TO IMPLANT A BACK-UP IN THE OPERATING ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22024069 ↗
• MalfunctionMay 8, 2025Impedance Problem; Impedance Problem

  IN SITU TESTING SHOWED AFFECTED CHANNELS.

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

  MAUDE report 21983219 ↗
• MalfunctionDec 23, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING WITH THE DEVICE IS AFFECTED. SINCE APPROXIMATELY 2-3 MONTHS, HE HAS INTERMITTENCIES AND VOLUME DECREASES WHEN MOVING THE JAW. THE USER ALSO REPORTED PAIN IN THE EAR AND AROUND THE EAR WHEN LAYING ON THAT SIDE. PER CLINICAL SUPPORT, FURTHER TROUBLESHOOTING SHOULD BE APPLIED, LIKE WEARING A TIGHT HEADBAND OR RECOMMENDING THE USER TO PRESS/MASSAGE THE STIMULATOR AREA IN CASE INTERMITTENCY IS RECOGNIZED.

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

  MAUDE report 20999221 ↗
• MalfunctionOct 14, 2024Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  THE USER DID NOT EXPERIENCE SATISFACTORY SPEECH PERCEPTION SINCE IMPLANTATION. AS PER EXPLANT REPORT FORM INFORMATION, 1 OR 2 CHANNELS WERE FOUND OUTSIDE FROM THE COCHLEA AT EXPLANTATION. THE USER WAS RE-IMPLANTED WITH A LONGER ELECTRODE ARRAY.

  Patient problems: Failure of Implant

  MAUDE report 20437576 ↗
• MalfunctionOct 11, 2024Circuit Failure; Circuit Failure

  AFTER CHANGING THE RONDO 3 AUDIO PROCESSOR, THE USER DID NOT HAVE ANY SOUND FROM THE DEVICE. THE USER HAS BEEN RE-IMPLANTED ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 20425422 ↗
• MalfunctionSep 26, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE EXPLANTED DEVICE WAS RECEIVED FOR INVESTIGATION.

  Patient problems: Implant Pain

  MAUDE report 20307471 ↗
• MalfunctionSep 24, 2024Electrical Shorting; Electrical Shorting

  AFTER IMPLANTING THE DEVICE IN THE INITIAL SURGERY ON (B)(6) 2024, INTRAOPERATIVE MEASUREMENTS SHOWED 7 SHORT-CIRCUITED CHANNELS. THERE WERE ALSO NO RESPONSES ON AUTOART. IT WAS DECIDED TO EXPLANT THE DEVICE AND USE THE BACK-UP INSTEAD. THE BACK-UP WAS SUCCESSFULLY IMPLANTED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20290544 ↗
• MalfunctionSep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE HAS BEEN RECEIVED AT HQ FOR INVESTIGATION. AS PER INFORMATION ON THE DEVICE EXPLANT REPORT FORM THE DEVICE WAS EXPLANTED DUE TO INCREASING PAIN AND DIZZINESS, ELEVATED IMPEDANCES AND SHORT CIRCUITS. THE USER HAS BEEN RE-IMPLANTED WITH A NEW DEVICE.

  Patient problems: Implant Pain

  MAUDE report 20244911 ↗
• MalfunctionAug 23, 2024Impedance Problem; Lack of Effect; Impedance Problem; Lack of Effect

  THE USER SUSTAINED A HEAD TRAUMA. THE USER INITIALLY REPORTED NO SIGNIFICANT CHANGE TO HEARING IMPRESSION AT THE TIME OF TESTING, WHICH WAS SHORTLY AFTER THE TRAUMA. IT WAS ADVISED TO MONITOR FOR CHANGES TO HEARING IMPRESSION AND ELECTRODE STATUS. AS PER FURTHER CLARIFICATION RECEIVED FROM THE FIELD, THERE WAS A DECREASE IN HEARING PERFORMANCE OVER TIME. RE-IMPLANTATION HAS BEEN DONE ON (B)(6) 2024.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 20046650 ↗
• MalfunctionJul 25, 2024Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. IT WAS REPORTED THAT UPON ACTIVATION, THE USER EXHIBITED NO AUDITORY RESPONSE FOR 5-6 ELECTRODES. AN X-RAY REVEALED THAT AT LEAST SEVEN ELECTRODES WERE OUTSIDE THE COCHLEA. A RE-INSERTION SURGERY HAS BEEN SUCCESSFULLY PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 19826492 ↗
• MalfunctionJun 10, 2024Migration; Migration

  IT WAS REPORTED THAT THE ELECTRODE MIGRATED FROM THE COCHLEA WHICH WAS CONFIRMED BY IMAGING LEADING O A REVISION SURGERY. DURING THE REPOSITIONING SURGERY, THE FIRM ELECTRODE LEAD WAS ENCASED BY TISSUE ON THE UPPER MASTOIDECTOMY. SMALL MOVEMENTS OF THE TISSUE, CAUSED BY THE SURGICAL INSTRUMENTS, SHOWED SHIFTING MOVEMENTS ON THE LOWER PART OF THE LEAD TOWARDS THE POSTERIOR TYMPANOTOMY. NO FIXATION CLIP COULD BE USED INITIALLY DUE TO THE ANATOMY. DURING THE EXPOSURE OF THE IMPLANT BED, THE OUTGOING LEAD WAS MOST LIKELY DAMAGED BY THE SURGEON. THEREFORE, THE USER WAS REIMPLANTED WITH A NEW DEVICE IN THE SAME SURGERY.

  Patient problems: Failure of Implant

  MAUDE report 19496222 ↗
• MalfunctionApr 10, 2024Migration; Migration

  THE USER HAS NO AUDITORY IMPRESSION IN SINGLE-CHANNEL STIMULATION <40 QU IN THE INITIAL FITTING. THE USER HAS BEEN RE-IMPLANTED. ACCORDING TO THE EXPLANTATION REPORT THE DEVICE WAS DISLOCATED. IT IS ASSUMED THAT THE DISPLACEMENT OF THE IMPLANT HOUSING HAS CAUSED THE ELECTRODE TO MOVE OUT OF THE COCHLEAR IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 19078625 ↗

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-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