Mi1200 SYNCHRONY +FLEXsoft 09402Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 09008737094027), received between Oct 28, 2018 and Sep 24, 2026 — classified as 21 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Output Problem” (15 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. How this data works · Data updated Oct 13, 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 24, 2026Impedance Problem

  The user's parent reported hearing loss with the left device in late (b)(6) 2026.The user underwent reimplantation on (b)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879260 ↗
• InjuryAug 5, 2026Impedance Problem

  The user's parent reported a sudden hearing loss with the right CI in (b)(6) 2026.The user has been reimplanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50139122 ↗
• MalfunctionFeb 9, 2026Impedance Problem

  THE USER EXPERIENCED A SUDDEN LOSS IN HEARING WITH THE DEVICE. REIMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24289289 ↗
• MalfunctionOct 30, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS CONSIDERED, IF THE USER'S HEALTH STATUS ALLOWS SURGERY. OTHERWISE, MONITORING PERFORMANCE WITH THE CURRENT DEVICE WILL CONTINUE.

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

  MAUDE report 23424249 ↗
• InjurySep 23, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER HAS BEEN EXPLANTED. THE SKIN OVER THE DEVICE WAS NOT INTACT, THERE WAS A MASTOID FISTULA AND THE DEVICE HAD EXTRUDED THROUGH THE SKIN BEHIND THE EAR. THE USER WILL BE REIMPLANTED ON (B)(6) 2026.

  Patient problems: Skin Tears

  MAUDE report 23124294 ↗
• MalfunctionMay 21, 2025Impedance Problem; Impedance Problem

  AFFECTED IMPEDANCES WERE NOTICED DURING MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22061027 ↗
• MalfunctionMay 2, 2025Impedance Problem; Impedance Problem

  DURING IN SITU MEASUREMENTS ON 21.APR.2025 AFFECTED CHANNELS WERE NOTICED. REIMPLANTATION SURGERY IS CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947817 ↗
• MalfunctionMar 5, 2025Impedance Problem; Impedance Problem

  THE USER'S PARENTS NOTICED THAT THE USER HAD NO REACTION TO SOUNDS ON THE LEFT SIDE FOR ABOUT 2 MONTHS. FURTHER MEDICAL INTERVENTION IS SCHEDULED.

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

  MAUDE report 21525855 ↗
• MalfunctionFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS REPORTEDLY EXPLANTED DUE TO ACUTE PURULENT MASTOIDITIS. THE CLINIC CONFIRMED THAT THERE WAS NO CLAIM THAT THE DEVICE HAD CAUSED OR CONTRIBUTED TO THE NEED FOR THE EXPLANTATION. THE CLINIC FURTHER NOTED THAT THERE WAS SIGNIFICANT SWELLING IN THE POSTAURICULAR AREA. THE USER HAS RECEIVED ANTIBIOTICS AND HORMONAL THERAPY. THE USER ALSO HAD A SUBPERIOSTEAL ABCESS ON THE RIGHT, SPREADING TO THE SITE OF THE IMPLANT.

  Patient problems: Mastoiditis

  MAUDE report 21394274 ↗
• MalfunctionNov 12, 2024Impedance Problem; Impedance Problem

  THE USER HAS NO SOUND PERCEPTION WITH THE DEVICE.

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

  MAUDE report 20663176 ↗
• MalfunctionNov 8, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. ACCORDING TO THE USER'S PARENTS A TRAUMA TO THE HEAD IS LIKELY. THE USER WAS RE-IMPLANTED WITH A NEW DEVICE ON(B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 20638398 ↗
• MalfunctionNov 6, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS SUDDENLY AFFECTED. THE USER WAS REIMPLANTED ON (B)(6) 2024.

  Patient problems: Failure of Implant

  MAUDE report 20618453 ↗
• MalfunctionJul 8, 2024Insufficient Device Problem Information; Lack of Effect; Insufficient Device Problem Information; Lack of Effect

  THE USER REPORTS PROGRESSIVE HEARING LOSS AND TACTILE SENSATIONS ON THE RIGHT SIDE OVER THE LAST TWO WEEKS, WITH STINGING, PULSING SENSATION (LIKE ELECTRIC SHOCKS) DURING IN SITU MEASUREMENTS. THE USER HAS BEEN RE-IMPLANTED WITH A NEW DEVICE.

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

  MAUDE report 19690252 ↗
• MalfunctionMay 28, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IN SITU TESTING SHOWED AFFECTED CHANNELS. THE USER'S FAMILY REPORTED A DECREASE IN THE CHILD'S HEARING RESPONSE AFTER A TRAUMA TO THE HEAD. REIMPLANTATION IS CONSIDERED, BUT NO DATE IS KNOWN YET.

  Patient problems: Failure of Implant

  MAUDE report 19404880 ↗
• MalfunctionMay 28, 2024Impedance Problem; Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IN SITU TESTING SHOWED AFFECTED CHANNELS. A CT SCAN AND REIMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 19404853 ↗
• MalfunctionDec 1, 2023Impedance Problem; Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER FELL ON HIS HEAD ABOUT 2 WEEKS AGO AND LIKELY SUFFERED A CONCUSSION. EXPLANTATION IS PLANNED.

  Patient problems: Failure of Implant

  MAUDE report 18244916 ↗
• MalfunctionNov 13, 2023Impedance Problem; Impedance Problem

  IN SITU TESTING SHOWS AFFECTED CHANNELS. THE USER'S PARENTS ARE NOT CURRENTLY INTERESTED IN PUTTING THE USER THROUGH ANOTHER SURGERY FOR A REVISION.

  Patient problems: Failure of Implant

  MAUDE report 18118711 ↗
• MalfunctionSep 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTEDLY THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA TO THE HEAD. THE USER WAS GIVEN A LOANER RONDO 2 WITH OLD MAPS AT FOLLOW-UP APPOINTMENT AND REPORTS THAT SHE CAN HEAR AND UNDERSTAND BETTER WITH THIS LOANER PROCESSOR. SHE WILL RECEIVE A NEW PROCESSOR IN SEPTEMBER. AS SOON AS THE PATIENT HAS MADE AN APPOINTMENT AT THE CLINIC, THE IMPLANT CHECK WILL BE CARRIED OUT. HOWEVER, NO DATE WAS SCHEDULED YET.

  Patient problems: Insufficient Information

  MAUDE report 17676151 ↗
• InjuryNov 10, 2022Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem; Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem

  THE USER WAS EXPLANTED ON (B)(6).2022 DUE TO INFECTION WITH WOUND HEALING PROBLEMS. AFTER TWO FAILED ATTEMPTS TO CLOSE THE WOUND THE CLINIC DECIDED TO PROCEED WITH EXPLANTATION. INFORMATION WAS RECEIVED THAT THE USER MIGHT BE REIMPLANTED IN THE FUTURE.

  Patient problems: Bacterial Infection

  MAUDE report 15771265 ↗
• InjuryJan 24, 2022Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available

  THE ELECTRODE ARRAY MAY HAVE ADDITIONALLY MIGRATED AFTER AN INCOMPLETE INSERTION AT IMPLANTATION. THE USER WAS REIMPLANTED ON THE (B)(6) 2021. THIS REPORT REFERS TO 9710014-2021-00878. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 13331940 ↗
• MalfunctionNov 16, 2021Migration; Migration

  THE ELECTRODE ARRAY MAY HAVE ADDITIONALLY MIGRATED AFTER AN INCOMPLETE INSERTION AT IMPLANTATION. THE USER WAS INITIALLY IMPLANTED WITH AN IMAGE-GUIDED MINIMALLY INVASIVE APPROACH, HOWEVER THE CLINIC WAS UNABLE TO ACHIEVE FULL INSERTION AND THE 2 MOST BASAL CHANNELS WERE LEFT EXTRA-COCHLEAR. THEN AT ACTIVATION NO AUDITORY PERCEPT WAS FOUND ON TWO MORE CHANNELS. THE USER WAS RE-IMPLANTED ON THE (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12819232 ↗
• InjuryJun 28, 2021Output Problem; Output Problem

  THE USER HAS EXPERIENCED NO BENEFIT WITH THE DEVICE SINCE THE LAST REVISION SURGERY THAT TOOK PLACE ON THE (B)(6) 2018 AND IS ALSO SUFFERING FROM AN INFECTION AND FROM PAIN, WHICH LED TO EXPLANTATION. THE REVISION SURGERY WAS A TYMPANOMASTOID-REVSISION WITHOUT CI EXPLANTATION. THERE ARE NO PLANS TO REIMPLANT THE USER, BECAUSE THE INFECTION HAS DAMAGED THE COCHLEA. ACCORDING TO THE EXPLANT REPORT FORM 6 CHANNELS WERE FOUND EXTRA-COCHLEA AT EXPLANTATION.

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

  MAUDE report 12075832 ↗
• InjuryJun 18, 2021Output Problem; Output Problem

  THE USERS HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USERS FAMILY REPORTED A FALL THAT RESULTED IN A TRAUMA TO THE HEAD ON THE LEFT SIDE. THE RECIPIENT WAS REIMPLANTED ON (B)(6) 2021. THIS REPORT REFERS TO 9710014-2020-00283. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 12023536 ↗
• MalfunctionMay 26, 2021Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER ATTENDED THE HOSPITAL ER IN MARCH WITH SEVERE HEADACHES AND HE ALSO DESCRIBED A SHOCKING SENSATION. THE USER HASN'T WORN THE PROCESSOR FOR SEVERAL MONTHS AND STILL WAS EXPERIENCING THE HEADACHES. THE HEADACHES ARE SIGNIFICANTLY WORSE DURING THE USE OF THE DEVICE. THE PROBLEMS HAD STARTED BETWEEN (B)(6) 2019 AND (B)(6) 2020. HE HAS SHOOTING PAINS ABOUT 3 CM ABOVE HIS CI, AND A DULL ACHE AND MILD PALPABLE TENDERNESS, HE IS ALSO SUFFERING FROM EPISODIC VERTIGO. SHOOTING SENSATION IS PRESENT WITH AND WITHOUT THE DEVICE, HOWEVER THE SHOCKING SENSATION IS ONLY PRESENT WITH THE DEVICE. ACCORDING TO AN UPDATE FROM THE CLINIC FROM THE (B)(6) 2021 THE USER IS NOW STABLE AFTER SEEN BY THE PAIN MANAGEMENT CLINIC.

  Patient problems: Failure of Implant; Headache

  MAUDE report 11884032 ↗
• InjuryApr 21, 2021Output Problem; Output Problem

  THE USERS HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USERS FAMILY REPORTED A FALL THAT RESULTED IN A TRAUMA TO THE HEAD ON THE LEFT SIDE. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 11699076 ↗

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 Product
• 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. Mi1000 CONCE