Mi1200 SYNCHRONY PIN +FLEX24 09401Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 09008737094010), received between Feb 1, 2018 and May 11, 2026 — classified as 8 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (13 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED AFTER MULTIPLE TRAUMAS TO THE HEAD. REIMPLANTATION IS CONSIDERED.

  Patient problems: Head Injury

  MAUDE report 25136937 ↗
• MalfunctionMar 5, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED AFTER A HEAD TRAUMA. THE USER WAS REIMPLANTED ON (B)(6) 2026.

  Patient problems: Head Injury

  MAUDE report 24516443 ↗
• MalfunctionNov 14, 2025Impedance Problem; Insufficient Device Problem Information; Impedance Problem; Insufficient Device Problem Information

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER WAS REIMPLANTED ON (B)(6) 2025.

  Patient problems: Head Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552182 ↗
• MalfunctionSep 24, 2025Impedance Problem; Impedance Problem

  IN SITU MEASUREMENTS SHOWED AFFECTED CHANNELS. THE USER WAS REIMPLANTED ON (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23134273 ↗
• InjuryAug 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  IMMEDIATELY AFTER IMPLANTATION, SWELLING BEGAN. ANTIBIOTIC TREATMENT HELPED TEMPORARILY.

  Patient problems: Skin Tears

  MAUDE report 22802300 ↗
• MalfunctionJun 17, 2025Impedance Problem; Impedance Problem

  CURRENTLY, THE PATIENT IS DISSATISFIED WITH THE SOUND QUALITY FROM THE LEFT COCHLEAR IMPLANT AND HAS FIVE ELECTRODES TURNED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22231126 ↗
• MalfunctionFeb 19, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A FALL. THE USER NOTICED A SUDDEN CHANGE IN HEARING WITH THE DEVICE BUT MENTIONED THAT HE DID NOT HIT HIS HEAD.THE USER WILL BE REIMPLANTED, NO DATE HAS BEEN SET YET FOR THE SURGERY.

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

  MAUDE report 21409079 ↗
• MalfunctionDec 5, 2024Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. RE-IMPLANTATION SURGERY HAS BEEN SCHEDULED FOR (B)(6) 2024.

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

  MAUDE report 20853900 ↗
• MalfunctionDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS REMOVED DUE TO AN INFECTION CAUSED BY THE BREAKDOWN OF THE BLIND SAC CLOSURE WOUND. THE USER ALSO HAD A RECURRENT CHOLESTEATOMA. ADDITIONALLY THE USER ALSO HAS EXPERIENCED AN INCREASING NUMBER OF AFFECTED CHANNELS SINCE 2020. RE-IMPLANTATION IS BEING CONSIDERED BUT WILL TAKE A WHILE AS IT HAS TO BE ENSURED THAT CHOLESTEATOMA DOESN'T RETURN. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 20832677 ↗
• MalfunctionOct 22, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE HAS DECREASED. THE USER WAS REIMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20506629 ↗
• MalfunctionDec 27, 2023Impedance Problem; Insufficient Device Problem Information; Impedance Problem; Insufficient Device Problem Information

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA TO THE HEAD. THE USER WAS REIMPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18398071 ↗
• MalfunctionNov 14, 2023No Device Output; Impedance Problem; No Device Output; Impedance Problem

  IN SITU TESTING SHOWED AFFECTED CHANNELS AND HEARING PERFORMANCE IS AFFECTED. A CT SCAN IS CONSIDERED. THE FAMILY AND SURGEON WILL BE CONSULTED REGARDING THE NEXT STEPS.

  Patient problems: Failure of Implant

  MAUDE report 18128578 ↗
• MalfunctionAug 21, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED, AND IT WAS REPORTED TO HAVE STEADILY DECREASED SINCE (B)(6) 2021. REVISION SURGERY IS BEING CONSIDERED BUT NO DATE HAS BEEN SET.

  Patient problems: Failure of Implant

  MAUDE report 17583857 ↗
• MalfunctionSep 8, 2022Output Problem; Output Problem

  THE USERS HEARING WITH THE DEVICE WAS AFFECTED. CLINICAL SUPPORT WAS CONTACTED AND BASED ON THEIR RECOMMENDATION THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 15379762 ↗
• MalfunctionAug 16, 2022Output Problem; Migration; Output Problem; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. REPORTEDLY THE HEARING PERFORMANCE WITH THE DEVICE HAS STARTED TO DECREASE 6 MONTHS AFTER THE INITIAL IMPLANTATION. THE SOUNDS ARE DESCRIBED BY THE USER AS "CRACKLY", "NOISY" AND "UNCLEAR". CT SCAN HAS BEEN ORDERED, BUT HAS NOT YET BEEN PERFORMED. ADDITIONAL MAPPING AND REVISION SURGERY ARE BEING CONSIDERED.

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 15233586 ↗
• MalfunctionMay 30, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  IN SITU TESTING REVEALED AFFECTED CHANNELS. THE USER REPORTED NOT USING THE DEVICE SINCE SOUND QUALITY WAS POOR AND A FEW MONTHS AGO HE EXPERIENCED SOME PAIN AROUND THE MAGNET SITE. IT WAS SUGGESTED AN APPOINTMENT BE MADE WITH ENT AND AN X-RAY TO CHECK THE IMPLANT SITE.

  Patient problems: Failure of Implant

  MAUDE report 14539363 ↗
• InjuryDec 3, 2021Output Problem; Output Problem

  DURING A CHECKUP 7 WEEKS AFTER THE INITIAL IMPLANTATION AFFECTED CHANNELS WERE NOTICED. REIMPLANTATION SURGERY WAS PERFORMED ON THE (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12924320 ↗
• MalfunctionMar 5, 2021Migration; Migration

  THE USER SHOWED SYMPTOMS OF FACIAL NERVE STIMULATION IN (B)(6) 2021 WHILE PERCEIVING HIGH PITCHED SOUND WITH THE DEVICE. REPORTEDLY, THE USERS PERFORMANCE WITH THE DEVICE HAS NEVER BEEN ADEQUATE. AT AN APPOINTMENT ON THE 4TH MARCH REPORTEDLY THE USER HAD OKAY HEARING PERFORMANCE. THE USER WAS RE-MAPPED.

  Patient problems: Failure of Implant; Undesired Nerve Stimulation

  MAUDE report 11419863 ↗
• MalfunctionJan 27, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER WAS EXPERIENCING DIZZINESS AND LOUD SOUNDS WITH THE IMPLANT. THE USER WAS TRAVELLING IN EUROPE IN DECEMBER WHEN THE LOUD SOUNDS STARTED. PRIOR TO THE TRIP, HE NOTICED A GRADUAL DECREASE IN SOUND QUALITY AND PERFORMANCE. ON NEW YEAR'S EVE HE REPORTED THAT THE DIZZINESS AND VERTIGO BEGAN, DESCRIBING A SUDDEN ONSET THAT HE ASSOCIATED WITH WEARING THE PROCESSOR BUT ALSO EXPERIENCED WITHOUT PROCESSOR USE. THE LOUD SOUNDS ARE ONLY PRESENT WHEN HE IS WEARING THE PROCESSOR. REPORTEDLY, THE USER HAD BEEN WEARING HIS DEVICE CONSISTENTLY BEFORE THE PROBLEMS BEGAN. THE USER WILL ATTEND ROUTINE FOLLOW-UPS AND NO FURTHER MEDICAL INTERVENTION IS PLANNED.

  Patient problems: Dizziness; Vertigo

  MAUDE report 9632130 ↗
• InjuryDec 2, 2019Output Problem; Output Problem

  SOUNDS BEING TOO SOFT WAS REPORTED ON (B)(6) 2019 AND RE-MAPPING WAS PERFORMED. PARENT RECOGNIZED THAT RECIPIENT WASN'T RESPONDING AS WELL AS BEFORE. NO TRAUMA / ACCIDENT WAS REPORTED OR CHANGES IN MEDICAL CONDITION. IN SITU MEASUREMENTS SHOWED AFFECTED CHANNELS AND HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER WAS SUCCESSFULLY RE-IMPLANTED ON (B)(6) 2019. THIS REPORT REFERS TO 9710014-2019-00741. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 9393475 ↗
• InjurySep 10, 2019Output Problem; Output Problem

  IN SITU TESTING REVEALED AFFECTED CHANNELS. X-RAY IMAGES SHOW THAT ALL CONTACTS ARE WITHIN THE COCHLEA. THERE WAS NO REDNESS OR SWELLING AROUND THE IMPLANT SITE. THE USER WAS RE-IMPLANTED ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 8978861 ↗
• InjuryMay 13, 2019Output Problem; Output Problem

  THE RECIPIENT NOTICED A DECREASE IN QUALITY OF HEARING WITH THE DEVICE WITHIN THE LAST WEEKS. THERE WAS NO EVENT (I.E. TRAUMA / ACCIDENT) RELATED TO THE CHANGE IN HEARING.

  Patient problems: Failure of Implant

  MAUDE report 8603044 ↗
• InjuryApr 7, 2019Output Problem; Output Problem

  RECIPIENT WAS SEEN FOR MAPPING AND NO RESPONSES WERE NOTED WITH THE RIGHT SIDE DEVICE. NO RECENT ILLNESSES, INJURIES, OR HEAD TRAUMA WAS REPORTED. DEVICE WAS EXPLANTED ON (B)(6) 2019, NO NEW DEVICE WAS IMPLANTED SINCE DURING EXPLANTATION POCKETS OF INFECTION SURROUNDING THE DEVICE WERE ENCOUNTERED. THE LEAD WAS CUT AND LEFT IN THE COCHLEA. RE-IMPLANTATION WAS POSTPONED ALLOWING THE TISSUE TO HEAL AND WILL BE PERFORMED AFTER COMPLETE RECOVERY IN SEVERAL MONTHS.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 8489971 ↗
• InjuryDec 21, 2018Migration; Migration

  THE DEVICE HAS REPORTEDLY MIGRATED AND A REPOSITIONING SURGERY WAS DISCUSSED. HOWEVER, AS THE RECIPIENT HAS NEVER LIKED THE SOUND QUALITY OF THE DEVICE WITH THE ACOUSTIC COMPONENT IT IS PLANNED INSTEAD TO EXPLANT THIS DEVICE AND RE-IMPLANT WITH A +FLEX28, WHICH IS WHAT IS ON THE CONTRA-LATERAL SIDE.

  Patient problems: Failure of Implant; No Information; Undesired Nerve Stimulation

  MAUDE report 8188708 ↗
• InjuryAug 21, 2018Output Problem; Output Problem

  THE RECIPIENT'S HEARING PERFORMANCE WITH THE DEVICE HAS DECREASED BETWEEN 6 AND 12 MONTHS POST-ACTIVATION. HE REPORTS INTERMITTENCIES IN SOUND AND HIS ABILITY TO UNDERSTAND SPEECH FLUCTUATES. NO INCIDENT OF ACCIDENT OR TRAUMA IS REPORTED. RE-IMPLANTATION HAS BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 7800539 ↗

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-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