Mi1250 SYNCHRONY 2 PIN FLEX28 S-Vector Magnet 39544Recalls & reported problems

Summary

The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 09008737395445), received between Oct 5, 2020 and Sep 28, 2026 — classified as 21 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Migration” (14 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 25 most recent of 51 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Impedance Problem

  The user came to the clinic because of low hearing performance. Re-implantation was done on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911260 ↗
• InjuryAug 20, 2026Device Appears to Trigger Rejection

  Swelling at the receiver/stimulator site of the left cochlear implant was observed one month post implantation surgery. Despite antibiotic therapy, the swelling did not improve, and the device eventually extruded and was therefore explanted.

  Patient problems: Skin Tears

  MAUDE report 50338442 ↗
• InjuryAug 13, 2026Migration

  There was a migration of the electrode array out of the cochlea with 5 extra-cochlear channels. The user was reimplanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50234351 ↗
• MalfunctionJul 17, 2026Migration

  IN SITU TESTING SHOW AFFECTED CHANNELS. REVISION SURGERY IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25852083 ↗
• MalfunctionJul 1, 2026Impedance Problem

  In-situ measurements show an increase in channels affected by high impedances since may 2023. Due to complex medical history, re-implantation is not recommended; The Audiologist is re-programming the right processor for sound awareness, disabling the HI electrodes and electrodes showing significant fluctuation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25675789 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  THE USER HAS BEEN SUFFERING FROM AN INFECTION AROUND THE IMPLANT'S STIMULATOR AND HAS BEEN HOSPITALIZED. IT IS PLANNED TO EXPLANT THE USER AND LEAVE THE ELECTRODE ARRAY INSIDE THE COCHLEA, SO THAT THE USER CAN BE REIMPLANTED ONCE THE INFECTION IS SORTED.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 25619050 ↗
• InjuryJun 2, 2026Adverse Event Without Identified Device or Use Problem

  THERE WAS NO HEARING IMPRESSION. THE USER HAS BEEN EXPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 25360497 ↗
• MalfunctionMay 12, 2026Migration

  NO HEARING SENSATION WITH THE IMPLANT AT FIRST FITTING. REPOSITIONING SURGERY IS SCHEDULED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146568 ↗
• MalfunctionMar 23, 2026Migration

  USER HAS BEEN EXPERIENCING TINNITUS SINCE IMPLANTATION, BOTH WITH AND WITHOUT AP. USER IS SCHEDULED ON (B)(6) 2026 FOR RECEIVER/STIMULATOR ADJUSTMENT.

  Patient problems: Tinnitus

  MAUDE report 24660302 ↗
• InjuryMar 3, 2026Device Appears to Trigger Rejection

  REPORTEDLY, THE MUSCLE FLAP WAS OPEN DUE TO A TOO STRONG MAGNET. THE DEVICE HAS EXTRUDED THROUGH THE SKIN. THE DEVICE WAS EXPLANTED.

  Patient problems: Skin Tears

  MAUDE report 24495922 ↗
• MalfunctionFeb 23, 2026Migration

  AT THE INITIAL ACTIVATION THE USER COULD ONLY HEAR ON THE FIRST 4 ELECTRODES. AN X-RAY IS PLANNED AND THEN IT WILL BE DECIDED HOW TO PROCEED. HOWEVER, RE-POSITIONING IS BEING CONSIDERED, IF THE IMAGES SHOWS THAT THE ELECTRODE ARRAY IS OUTSIDE THE COCHLEA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413750 ↗
• MalfunctionDec 19, 2025Migration; Migration

  THE USER HAS HAD POORER PERFORMANCE THAN EXPECTED SINCE ACTIVATION AND FACIAL STIMULATION. PATIENT HAS REPORTED ABNORMAL SOUND QUALITY MUMBLING WITH NO CLARITY OF SPEECH. ALSO REPORTS PINGING WHEN TOUCHING PINNA AND WITH JAW MOVEMENTS. RE-INSERTION WAS SUCCESSFULLY PERFORMED. THE FACIAL NERVE WAS DEHISCENT IN THE FACIAL RECESS. THE SURGEON PLACED A BIT OF TISSUE OVER THE FACIAL NERVE TO PROTECT IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Undesired Nerve Stimulation

  MAUDE report 23847855 ↗
• MalfunctionNov 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THERE WAS A REVISION SURGERY 5 DAYS AFTER IMPLANTATION (DUE TO ELECTRODE DISLOCATION/INCORRECT POSITION) IN WHICH THE DEVICE WAS REMOVED TO A SALINE BATH AND RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23448230 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER WAS EXPLANTED DUE TO A WOUND INFECTION WHICH STARTED A FEW WEEKS PRIOR. THE USER WILL BE REIMPLANTED.

  Patient problems: Post Operative Wound Infection

  MAUDE report 23307478 ↗
• MalfunctionSep 10, 2025Migration; Migration

  THE USER IS GETTING VERY LIMITED BENEFIT FROM HIS DEVICE. IMAGING HAS BEEN REQUESTED.

  Patient problems: Discomfort

  MAUDE report 23014404 ↗
• MalfunctionAug 20, 2025Impedance Problem; Impedance Problem

  THE USER CAN NO LONGER HEAR WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22847509 ↗
• MalfunctionAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER IS HAVING SOME COMPLICATIONS AND LOTS OF PAIN AT THE SURGERY SITE. THE USER WILL UNDERGO EXPLANT SURGERY DUE TO LACK OF BENEFIT AND WILL NOT BE REIMPLANTED. SURGERY IS NOT YET SCHEDULED.

  Patient problems: Implant Pain

  MAUDE report 22791324 ↗
• InjuryJul 7, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE ELECTRODE LEAD EXTRUDED INTO THE AUDITORY CANAL. THE USER HAS BEEN EXPLANTED.

  Patient problems: Skin Tears

  MAUDE report 22411085 ↗
• MalfunctionMay 26, 2025Migration; Migration

  THE USER REPORTED A CHANGING/DETERIORATING HEARING IMPRESSION AND UNDERWENT A RE-POSITIONING SURGERY ON (B)(6) 2025 BECAUSE OF AN ELECTRODE MIGRATION. NOT ALL CHANNELS COULD BE REINSERTED DURING REVISION SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084681 ↗
• InjuryMay 2, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REPORTEDLY, THE ELECTRODE LEAD EXTRUDED THROUGH THE EAC. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Skin Tears

  MAUDE report 21947813 ↗
• MalfunctionMar 28, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTEDLY, THE USER COULD NOT HEAR WITH THE DEVICE AND A DEVICE DEFECT WAS ASSUMED.THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21717260 ↗
• MalfunctionMar 5, 2025Impedance Problem; Impedance Problem

  6 MONTHS AFTER IMPLANTATION, IN (B)(6) 2025, THE USER'S FATHER REPORTED THAT THE LEFT SIDE DEVICE WASN'T WORKING FOR 2 MONTHS AND THE USER WAS ONLY WEARING THE RIGHT SIDE. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 21525570 ↗
• InjuryFeb 25, 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 OVER THE IMPLANT HOUSING.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 21456887 ↗
• InjuryFeb 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WAS SENT TO THE EMERGENCY DEPARTMENT ON (B)(6) 2025 AND THEN FOLLOWED UP WITH A PHYSICIAN. THEY DID A CT AND GAVE A PRESSURE DRESSING AS WELL AS ORAL ANTIBIOTICS. THE USER CONTINUED TO EXPERIENCE ONGOING PAIN AND SWELLING; THUS, HE UNDERWENT A PROCEDURE ON (B)(6) 2025 TO EVACUATE INFECTION AND BLOOD FROM UNDER THE SKIN FLAP AND ASSESS IMPLANT INTEGRITY, WHICH WAS CONFIRMED AS FUNCTIONING NORMALLY, AND THE CLINIC DECIDED TO PRESERVE THE CURRENT DEVICE WITH PLANS FOR POTENTIAL USE IN 3-4 WEEKS IF HEALING PROGRESSES. THIS REPORT REFERS TO 9710014-2025-00123. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Unspecified Infection

  MAUDE report 21371673 ↗
• MalfunctionFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER WAS SENT TO THE EMERGENCY DEPARTMENT ON (B)(6) 2025 AND THEN FOLLOWED UP WITH A PHYSICIAN DU TO SWELLING AND PAIN. THEY DID A CT AND GAVE A PRESSURE DRESSING AS WELL AS ORAL ANTIBIOTICS. THE USER CONTINUED TO EXPERIENCE ONGOING PAIN AND SWELLING; THUS, HE UNDERWENT A PROCEDURE ON (B)(6) 2025 TO EVACUATE INFECTION AND BLOOD FROM UNDER THE SKIN FLAP AND ASSESS IMPLANT INTEGRITY, WHICH WAS CONFIRMED AS FUNCTIONING NORMALLY, AND THE CLINIC DECIDED TO PRESERVE THE CURRENT DEVICE WITH PLANS FOR POTENTIAL USE IN 3-4 WEEKS IF HEALING PROGRESSES.

  Patient problems: Unspecified Infection

  MAUDE report 21353397 ↗

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-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-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