Mi1250 SYNCHRONY 2 FLEX24 S-Vector Magnet 39543Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 09008737395438), received between Oct 5, 2021 and Aug 5, 2026 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Migration” (12 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Insufficient Device Problem Information

  The device failed the testing in the operating room.

  Patient problems: Insufficient Information

  MAUDE report 50141658 ↗
• MalfunctionApr 2, 2026Migration

  5 ELECTRODES ARE REPORTED EXTRA COCHLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766607 ↗
• MalfunctionJan 30, 2026Migration

  HEARING PERFORMANCE HAS BEEN AFFECTED. IMAGING CONFIRMS THREE CHANNELS HAVE MIGRATED OUT OF THE COCHLEA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219748 ↗
• MalfunctionJan 27, 2026Impedance Problem; Device Handling Problem

  AFTER ELECTRODE INSERTION IN SITU MEASUREMENTS REVEALED HIGH IMPEDANCES. IT WAS TRIED TO MASSAGE STIMULATOR, ADD SALINE ONTO GROUND ELECTRODE, ENSURE STRONG COUPLING, CHANGE TESTING COIL, REDUCE LAYERS BETWEEN TESTING DEVICE AND IMPLANT, BUT IT STILL SHOWED HIGH IMPEDANCES ON ALL 12 CONTACTS. THE DEVICE WAS REMOVED AND THE BACK-UP IMPLANT WAS USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190033 ↗
• MalfunctionJan 13, 2026Migration

  THE DEVICE WAS EXPLANTED DUE TO ELECTRODE MIGRATION FROM THE COCHLEA. CT SCAN WAS ORDERED AND CONFIRMED THE MIGRATION. THE USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051135 ↗
• MalfunctionSep 29, 2025Impedance Problem; Impedance Problem

  THE USER HAS BEEN REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23167266 ↗
• MalfunctionSep 26, 2025Impedance Problem; Impedance Problem

  PARENTS NOTED THAT THE USER REFUSED TO WEAR LEFT DEVICE IN ISOLATION. RE-IMPLANTATION WAS RECOMMENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23153411 ↗
• MalfunctionJul 17, 2025Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration

  AN ABSCESS WAS NOTED BEHIND THE RIGHT EAR CAUSING THE ARRAY TO EXTRUDE FROM THE COCHLEA. IT WAS REINSERTED AT THE TIME.

  Patient problems: Abscess; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529742 ↗
• InjuryJul 17, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AN ABSCESS WAS NOTED BEHIND THE RIGHT EAR CAUSING THE ARRAY TO EXTRUDE FROM THE COCHLEA. IT WAS REINSERTED AT THE TIME.

  Patient problems: Abscess

  MAUDE report 22529737 ↗
• MalfunctionMay 26, 2025Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. REPORTEDLY, THE ELECTRODE IS DISPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22083467 ↗
• MalfunctionFeb 14, 2025Migration; Migration

  A REVISION SURGERY IS SCHEDULED FOR ON (B)(6) 2025. AUDIOLOGIST REPORTS THAT THE USER IS EXPERIENCING A LIKELY MIGRATION OF THE DEVICE. THE SURGEON PLANS TO EITHER RE-INSERT CURRENT DEVICE OR EXPLANT AND RE-IMPLANT A NEW DEVICE.

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

  MAUDE report 21383597 ↗
• MalfunctionNov 29, 2024Impedance Problem; Impedance Problem

  A CHANGE IN IMPEDANCES OVER LAST FEW MONTHS HAS BEEN REPORTED. AT THE LAST VISIT MORE CHANNELS WERE REPORTED TO BE WITH HIGH IMPEDANCE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20809765 ↗
• MalfunctionOct 7, 2024Migration; Migration

  THE USER HAS BEEN EXPLANTED BECAUSE OF MIGRATION OF ELECTRODE OUT OF COCHLEA. REPORTEDLY, THERE WAS A COMPLETE OBLITERATION/SCLEROSIS OF COCHLEAR BECAUSE OF LABYRINTHITIS, THUS REINSERTION/REIMPLANTATION IS IMPOSSIBLE.

  Patient problems: Failure of Implant

  MAUDE report 20382397 ↗
• MalfunctionAug 1, 2024Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. REPORTEDLY, THE IMPLANT MIGRATED AND AT LEAST 3 ELECTRODE CHANNELS WERE EXTRA-COCHLEAR. RE-POSITIONING OF THE IMPLANT WAS NOT POSSIBLE DUE TO OSSIFICATION. THE USER WAS RE-IMPLANTED WITH A NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 19880254 ↗
• MalfunctionApr 19, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE USER'S HEARING HAS DECLINED WHEN THE USER IS ONLY WEARING THE LEFT CI. REPORTEDLY, IMPEDANCES HAVE ALSO SHOWN FLUCTUATIONS AND A NEW OPEN CIRCUIT HAS BEEN DETECTED. TESTING IN THE BOOTH HAS BEEN LIMITED DUE TO OTHER DEVELOPMENTAL DELAYS. RECENTLY, THE USER UNDERWENT CT SCANS, AND ALTHOUGH THE REPORTS DID NOT NOTE ANYTHING CONCERNING THE LEFT SIDE, IT IS NOTEWORTHY THAT SHE HAS EXTENSIVE TEMPORAL BONE ABNORMALITIES AND BILATERAL COCHLEAR NERVE DEFICIENCY. THERE ARE NO REPORTS OF ILLNESS, FEVER, OR HEAD TRAUMA, ALTHOUGH SHE EXPERIENCES FREQUENT 'TUMBLES.'

  Patient problems: Failure of Implant

  MAUDE report 19141598 ↗
• MalfunctionMar 14, 2024Impedance Problem; Migration; Impedance Problem; Migration

  BEFORE SURGEON CLOSED, HE VERIFIED FULL INSERTION OF ELECTRODE. POST-OP CT SCAN INDICATED THAT ELECTRODE HAD MIGRATED OUT OF COCHLEA, WITH 5 ELECTRODES EXTRA COCHLEAR.

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

  MAUDE report 18900617 ↗
• MalfunctionOct 9, 2023Impedance Problem; Insufficient Device Problem Information; Impedance Problem; Insufficient Device Problem Information

  THE USER RECENTLY HAD STREP AND PREVIOUSLY URI (UPPER RESPIRATORY INFECTION) VIRUS, AND RECENTLY FELL OFF A RECLINER AND HIT HER HEAD ABOUT 5 WEEKS AGO. AFTER THE FALL, THE COIL ON HER RIGHT PROCESSOR STARTED FLASHING RED, BUT WAS GREEN AGAIN AFTER REPLACING THE CABLE. THE USER THEN EXPERIENCED ISSUES WITH HER RIGHT IMPLANT, AND THE AUDIOLOGIST REQUESTED INTEGRITY TESTING AFTER NOTICING HIGH IMPEDANCES AT HER LAST VISIT. THE USER HAS BEEN REIMPLANTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17893707 ↗
• MalfunctionAug 17, 2023Malposition of Device; Malposition of Device

  USER PERFORMANCE HAS BEEN POOR SINCE ACTIVATION. A POST-OP OTOPLAN WAS REQUESTED WHICH REVEALED AN ABNORMAL INSERTION, NAMELY THE ARRAY WAS NOTED TO BE FOLDED OVER ON ITSELF WITH CHANNEL 5 APPEARING TO BE THE MOST APICAL CHANNEL SITING ABOUT 3500HZ. RE-IMPLANTATION IS PLANNED.

  Patient problems: Failure of Implant

  MAUDE report 17563410 ↗
• MalfunctionJul 12, 2023Migration; Migration

  THE FIELD WAS INFORMED THAT THE IMPLANT HOUSING ROTATED IN THE POCKET ANTERIORLY SUCH THAT THE MAGNET IS ABOVE THE EAR. THE ISSUE STARTED JULY 01, 2023. THERE WAS NO TRAUMA OR INCIDENT THAT THE FAMILY CAN DETERMINE CAUSED THIS MOVEMENT. REPOSITIONING TOOK PLACE ON (B)(6) 2023. THE SURGEON WAS ABLE TO SUCCESSFULLY REPOSITION THE DEVICE. UPON OPENING, THE PACKAGE OF THE DEVICE HAD MIGRATED AND ROTATED ANTERIORLY AND HAD PULLED THE LEAD CAUSING THE ELECTRODE TO MIGRATE FULLY OUTSIDE OF THE COCHLEA. THE SURGEON CREATED A 1 MM WELL AND CHANNEL AND FIXATED THE DEVICE WITH SCREWS AND SUTURES. ADDITIONALLY, HE FIXATED THE LEAD WITH AN INCUS BUTTRESS BRIDGE.

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

  MAUDE report 17304595 ↗
• MalfunctionMay 30, 2023Circuit Failure; No Device Output; Circuit Failure; No Device Output

  ON (B)(6), 2023 THE USER WAS SEEN IN THE CLINIC AND THERE WAS NO COMMUNICATION WITH THE PROCESSOR. THE LINK CHECK WOULD ONLY FLASH RED. THE USER WAS SEEN AGAIN ON (B)(6), 2023 AND THE PROBLEM STILL PERSISTED. THE USER HAD NO MORE BENEFIT WITH THE DEVICE. THE USER WAS RE-IMPLANTED ON (B)(6), 2023.

  Patient problems: Failure of Implant

  MAUDE report 17018383 ↗
• MalfunctionJan 3, 2023Migration; Migration

  INFORMATION WAS RECEIVED ON A COCHLEAR IMPLANT SURGICAL SURVEY THAT THERE WAS 1 HIGH CHANNEL AT IMPLANTATION. THE USER DID NOT HAVE GOOD PERFORMANCE AT ACTIVATION DUE TO THE PARTIAL INSERTION. REPORTEDLY, A FULL INSERTION OF THE FLEX24 ARRAY WAS ACHIEVED. HOWEVER, ACCORDING TO CLINICAL SUPPORT'S ANALYSIS OF THE IMAGING CHANNELS 7-12 ARE EXTRA-COCHLEAR BASED ON IMAGING PERFORMED ON THE (B)(6) 2022. REVISION SURGERY FOR THIS SIDE IS UNDER DISCUSSION.

  Patient problems: Failure of Implant

  MAUDE report 16085450 ↗
• MalfunctionSep 13, 2022Improper or Incorrect Procedure or Method; Output Problem; Improper or Incorrect Procedure or Method; Output Problem

  THE USER HAD AN ACCIDENT AND THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WAS EXPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15410718 ↗
• MalfunctionOct 5, 2021Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE USER HAS EXPERIENCED NON-AUDITORY STIMULATION/PERCEPTION ON MUCH OF THE ELECTRODE ARRAY SINCE ACTIVATION ON (B)(6) 2021. THE USER HAD A FOLLOW-UP APPOINTMENT ON (B)(6) 2021 IN WHICH SHOCKING SENSATION WAS FELT INTENSE AND SHARP. SINCE THE MOST RECENT PROGRAMMING IT IS REPORTED THAT THERE IS NO DISCOMFORT WITH SOUND AT HOME HOWEVER THE SOUND IS DESCRIBED AS VERY MUFFLED AND NOT SPEECH-LIKE. IMAGING IS PLANNED TO CHECK THE PLACEMENT OF THE ELECTRODE.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 12575289 ↗

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-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-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