Mi1250 SYNCHRONY 2 FLEX26 36902Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 09008737369026), received between Mar 24, 2020 and Sep 15, 2026 — classified as 13 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Migration” (11 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 38 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Impedance Problem

  Hearing performance with the device is affected.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771648 ↗
• InjurySep 2, 2026Migration

  User was re-implanted 1 month after initial implantation due to migration.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50563715 ↗
• InjurySep 1, 2026Device Appears to Trigger Rejection

  Implant site is swollen, and a wound with infection and extrusion reported.

  Patient problems: Tissue Breakdown

  MAUDE report 50544353 ↗
• MalfunctionAug 27, 2026Circuit Failure

  Hearing performance with the device has been affected after the user sustained a trauma to the head on the opposite side.

  Patient problems: Head Injury

  MAUDE report 50470608 ↗
• MalfunctionMay 13, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. SEVERE HEAD TRAUMA REPORTED.

  Patient problems: Head Injury

  MAUDE report 25159172 ↗
• MalfunctionMar 23, 2026Migration

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. REVISION SURGERY WAS PERFORMED BUT DURING SURGERY, THE DEVICE WAS DAMAGED. THE DEVICE WAS THEREFORE EXPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24660309 ↗
• MalfunctionMar 12, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24580426 ↗
• InjuryMar 6, 2026Device Appears to Trigger Rejection

  USER SUFFERED AN INFECTION 1 MONTH POST IMPLANTATION. DEVICE WAS EXPLANTED ON (B)(6) 2026.

  Patient problems: Post Operative Wound Infection; Skin Infection

  MAUDE report 24529283 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  THE SURGICAL WOUND BECAME INFECTED AND DID NOT HEAL. THE DECISION WAS MADE TO EXPLANT THE DEVICE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24505458 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  THE USER HAS A DISCHARGE FROM THE EAR AND MIDDLE EAR DUE TO A MIDDLE EAR INFECTION. REVISION SURGERY FOR MASTOID EXAMINATION HAS TAKEN PLACE ON (B)(6) 2025. REPORTEDLY, THE PATIENT HAD A SEROMA AND PROBLEMS WITH THE PROCESSOR AFTER THIS REVISION SURGERY. IT WAS DRY FOR ABOUT 3 WEEKS, THEN IT STARTED TO OOZE. BUT IT RESOLVED WITH COMPRESSION. THE ISSUES REOCCURRED; THUS, THE USER NEEDED ANOTHER SURGERY. THE USER HAS BEEN EXPLANTED ON (B)(6) 2026 DUE TO THE ONGOING MIDDLE EAR INFECTION AND SEROMA. AS PER DEVICE EXPLANT INFORMATION FORM, IT STARTED AS A MIDDLE EAR INFECTION THAT SPREAD TO THE LEVEL OF THE IMPLANT.

  Patient problems: Medical device site infection

  MAUDE report 24481036 ↗
• MalfunctionDec 5, 2025Impedance Problem; Impedance Problem

  THE USER HAD A TRAUMA TO THE RIGHT SIDE OF THE HEAD AFTER WHICH HE COULD NO LONGER HEAR. THE USER HAS BEEN REIMPLANTED.

  Patient problems: Head Injury

  MAUDE report 23725747 ↗
• MalfunctionOct 29, 2025Circuit Failure; Circuit Failure

  THERE IS NO COUPLING WITH THE IMPLANT AFTER SEVERE HEAD TRAUMA ON (B)(6) 2025. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: Head Injury

  MAUDE report 23411081 ↗
• MalfunctionOct 15, 2025Circuit Failure; Circuit Failure

  PARENTS SAY THAT THE USER START LEARNING WALKING SO IT MIGHT BE HE HAD A HEAD TRAUMA OVER THE IMPLANT SITE. RE-IMPLANTATION IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290184 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  BECAUSE OF INFLAMMATION, THE IMPLANT WAS REMOVED.

  Patient problems: Inflammation

  MAUDE report 22477524 ↗
• MalfunctionMay 6, 2025Device Handling Problem; Device Handling Problem

  SINCE IMPLANTATION OF THE IMPLANT, 4 CHANNELS HAVE BEEN DISABLED DUE TO BEING DAMAGED BECAUSE OF MULTIPLE MANIPULATIONS DURING ELECTRODE INSERTION. NOW ALSO CHANNEL 12 IS DISABLED BECAUSE OF PAIN. THE CLINIC IS CONSIDERING RE-IMPLANTATION WITH A NEW IMPLANT BECAUSE THE AUDIOLOGICAL AND SPEECH OUTCOMES ARE NOT GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965513 ↗
• MalfunctionJan 30, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE USER WAS IMPLANTED IN (B)(6) 2024 AND UNDERWENT A SECOND STAGE SURGERY IN (B)(6) 2024 FOR BLIND SAC CLOSURE. IT IS SUSPECTED THAT THE ELECTRODE MIGHT HAVE BEEN DISTURBED DURING REVISION. THE USER REPORTED POORER HEARING FOLLOWING REVISION AND NO BENEFIT AT FOLLOW UP IN (B)(6) 2024, THEREFORE REIMPLANTATION WAS DONE (B)(6) 2025. THE USER WILL BE SEEN AGAIN IN THE CLINIC IN (B)(6) 2025 FOR ACTIVATION OF THE NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 21272044 ↗
• InjuryDec 13, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER SUFFERED FROM INFECTION DUE TO OTITIS MEDIA. ANTIBIOTIC WAS GIVEN AND THE CONDITION OF THE PATIENT HAS IMPROVED. HOWEVER, THE SKIN WAS OPENED, THEREFORE SKIN REPAIR SURGERY WAS DONE TO REPAIR AND CLEAN THE SKIN.

  Patient problems: Tissue Breakdown

  MAUDE report 20922940 ↗
• MalfunctionDec 6, 2024Migration; Migration

  TWO DAYS AFTER THE INITIAL IMPLANTATION SURGERY, X-RAY IMAGES REVEALED MIGRATION OF THE ELECTRODE OUT OF THE COCHLEA. REVISION SURGERY HAS BEEN DONE.

  Patient problems: Failure of Implant

  MAUDE report 20862663 ↗
• MalfunctionSep 30, 2024Impedance Problem; Impedance Problem

  THE DEVICE WAS REMOVED DURING INITIAL SURGERY DUE TO AFFECTED CHANNELS. THE CLINIC DID NOT ENCOUNTER RESISTANCE DURING THE INSERTION AND THE CLINIC DID NOT NOTICE ANY OSSIFICATION. THE WOUND WAS REPORTEDLY SUTURE-CLOSED BEFORE THE BACKUP DEVICE WAS IMPLANTED, THERE WAS ONLY A SLIGHT DELAY OF 30 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332324 ↗
• MalfunctionAug 9, 2024Impedance Problem; Impedance Problem

  IT IS CURRENTLY UNKNOWN WHETHER THE USER'S HEARING PERFORMANCE HAS BEEN AFFECTED. AN INTEGRITY TEST WILL BE PERFORMED IN (B)(6) 2024. NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Failure of Implant

  MAUDE report 19947712 ↗
• MalfunctionJul 30, 2024Migration; Migration

  IT WAS REPORTED THAT IN SITU MEASUREMENTS AT THE INITIAL ACTIVATION OF THE DEVICE ON (B)(6) 2024 WERE INDICATIVE OF THE LAST 6 BASAL CHANNELS HAVING POSSIBLY MIGRATED OUT OF THE COCHLEA. THIS WAS LATER CONFIRMED BY X-RAY SCANS. A REVISION SURGERY IS BEING CONSIDERED TO REINSERT THE EXTRA-COCHLEAR CHANNELS. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 19858814 ↗
• MalfunctionJul 22, 2024Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT AFTER AN ACCIDENT, THE PATIENT WAS NO LONGER ABLE TO HEAR WITH THE DEVICE. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19793335 ↗
• MalfunctionFeb 29, 2024Impedance Problem; Impedance Problem

  THE USER CAN'T HEAR WELL WITH HIS CI. IF HE OPENED HIS MOUTH OR TURNS THE HEAD, HE CANNOT HEAR WITH THE DEVICE. THE USER SHOWED GOOD BENEFIT BEFORE. FOUR WEEKS AGO, THE IMPLANT AREA BECAME SLIGHTLY PAINFUL AND IT'S BEEN ABOUT TWO WEEKS SINCE HE HAS NO HEARING. THE PAIN WAS NOT PRESENT IF THE PATIENT WAS NOT WEARING THE PROCESSOR. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 18805711 ↗
• MalfunctionFeb 21, 2024Impedance Problem; Impedance Problem

  THE USER REPORTED A GENERAL DECREASE IN THE HEARING PERFORMANCE OF HIS DEVICE. HOWEVER, WHEN APPLYING PRESSURE TO THE PROCESSOR COIL, HE CLAIMED TO HEAR WELL. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 18746359 ↗
• InjuryOct 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER HAS AN INFECTION ON THE RIGHT SIDE AND SWELLING OVER THE IMPLANT. THE CLINIC SAID THAT THE IMPLANT IS EXPOSED THROUGH THE SKIN, AND THEY APPLIED A DRESSING OVER THE SKIN. THE SURGEON IS PLANNING TO DO REVISION SURGERY FOR INFECTION CLEANING. IT IS PROBABLE THEY WILL REMOVE THE IMPLANT AND CUT THE ELECTRODE FOR LATER RE-IMPLANTATION.

  Patient problems: Unspecified Infection

  MAUDE report 17858591 ↗

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