Mi1210 SYNCHRONY ST +FLEX28 33187Recalls & reported problems

Summary

The FDA's MAUDE database contains 141 adverse event reports that list this exact device (DI 09008737331870), received between Jul 20, 2018 and Jul 30, 2026 — classified as 48 injuries, 93 malfunctions.

The most frequently reported specific device problem is “Output Problem” (73 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 141 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Impedance Problem

  Accident/ trauma is reported.

  Patient problems: Head Injury

  MAUDE report 50080204 ↗
• MalfunctionFeb 25, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24439968 ↗
• MalfunctionFeb 23, 2026Circuit Failure; Impedance Problem

  IT WAS NOT POSSIBLE TO PERFORM IN SITU MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24411078 ↗
• MalfunctionFeb 13, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330428 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IN (B)(6) 2022 A SOFT TISSUE SWELLING WAS TREATED WITH ANTIBIOTICS. THE SWELLING REOCCURRED, THUS IN (B)(6) 2022 A NEEDLE ASPIRATION WAS PERFORMED. ON (B)(6) 2022 THE USER UNDERWENT SURGERY WHERE THE DEVICE WAS REMOVED FROM THE IMPLANT SITE, THE IMPLANT SIDE WAS CLEANED, AND THEN THE DEVICE WAS REIMPLANTED.

  Patient problems: Bacterial Infection

  MAUDE report 24276639 ↗
• MalfunctionFeb 6, 2026Impedance Problem

  THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24275872 ↗
• MalfunctionDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  HOWEVER, SHE BEGAN EXPERIENCING PAIN OVER THE IMPLANT SITE, WHICH MADE IT IMPOSSIBLE TO CONTINUE WEARING THE AP. CONSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2025. THE USER WAS RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 23825906 ↗
• MalfunctionNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER WAS ADMITTED TO HOSPITAL WITH A COMPLICATED DUCTAL CHOLESTEATOMA AND SOFT TISSUE INFECTION AT THE INTERNAL DEVICE SITE. A SUBTOTAL PETROSECTOMY AND EXPLANTATION OF THE DEVICE WERE PERFORMED ON (B)(6) 2025. SHE DEVELOPED POSTOPERATIVE MENINGITIS AND RECEIVED SIX WEEKS OF ANTIBIOTIC TREATMENT, TO WHICH SHE RESPONDED WELL.

  Patient problems: Cholesteatoma

  MAUDE report 23580128 ↗
• MalfunctionNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER'S IMPLANT WAS REMOVED DUE TO AN UNRESOLVABLE INFECTION IN THE IMPLANT AREA. THE INFECTION STARTED AROUND 6 YEARS AFTER INITIAL IMPLANTATION. REPORTEDLY, THE DEVICE WAS FUNCTIONAL PRIOR TO EXPLANTATION. THE USER WILL BE RE-IMPLANTED WITH A NEW DEVICE ONCE THE INFECTION HAS COMPLETELY HEALED.

  Patient problems: Unspecified Infection

  MAUDE report 23580097 ↗
• MalfunctionOct 7, 2025Impedance Problem; Impedance Problem

  THE USER HAS NO SOUND PERCEPTION WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23231184 ↗
• InjuryOct 5, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE MAGNET STRENGTH WAS ADJUSTED. DURING A ROUTINE MEDICAL EXAMINATION ON (B)(6) 2025 IT WAS NOTED THAT THE IMPLANT HOUSING IS PROTRUDING AND IS PARTIALLY EXPOSED.

  Patient problems: Skin Tears

  MAUDE report 23218276 ↗
• MalfunctionSep 23, 2025Impedance Problem; Impedance Problem

  THERE WAS A SUDDEN LOSS OF HEARING BENEFIT WITH THE DEVICE. THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23121566 ↗
• MalfunctionAug 12, 2025Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. REPORTEDLY, THERE WAS NO TRAUMA OR ACCIDENT, BUT THE USER'S GRANDMOTHER DESCRIBED THE CHILD AS "VERY ACTIVE". THE USER WILL BE SCHEDULED FOR IMAGING, FURTHER STEPS WILL BE DECIDED AFTERWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22781198 ↗
• MalfunctionMay 19, 2025Impedance Problem; Impedance Problem

  THE USER'S MOTHER REPORTED THAT HER DAUGHTER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. FURTHER STEPS ARE NOT KNOWN AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041644 ↗
• MalfunctionMay 2, 2025Migration; Migration

  A REVISION SURGERY TO REPOSITION THE IMPLANT HOUSING WAS PERFORMED ON (B)(6) 2025. IT SEEMS THAT THE ELECTRODE ARRAY WAS PULLED OUT OF COCHLEA DURING THIS SURGERY. ON (B)(6) 2025 A SECOND REVISION SURGERY WAS DONE TO RE-INSERT THE ELECTRODE ARRAY, HOWEVER, 1 CHANNEL WAS DAMAGED AND THE SURGEON DECIDED TO RE-IMPLANT THE USER WITH A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21947825 ↗
• MalfunctionApr 11, 2025Impedance Problem; Impedance Problem

  THE USER REPORTED INTERMITTENT FUNCTION WITH THE IMPLANT A FEW DAYS AGO. ACCORDING TO CLINICAL SUPPORT RE-IMPLANTATION MIGHT BE CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21823342 ↗
• MalfunctionMar 18, 2025Impedance Problem; Impedance Problem

  THE USER HAS A WORSENING IN SOUND PERCEPTION WITH THE DEVICE. ANYTIME SOON, THE USER WILL BE REPROGRAMMED IN ORDER TO CHECK THE IN SITU MEASUREMENTS AGAIN AND ITS VARIATIONS.

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

  MAUDE report 21628673 ↗
• MalfunctionMar 11, 2025Circuit Failure; Circuit Failure

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER HE HIT HIS HEAD. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 21571058 ↗
• MalfunctionMar 6, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IT WAS REPORTED THAT THE USER HAD A TRAUMA TO THE HEAD ABOUT ONE MONTH AGO. THERE WAS NO SWELLING OR REDNESS SEEN OVER THE IMPLANT AREA. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 21534794 ↗
• MalfunctionFeb 26, 2025Circuit Failure; Insufficient Device Problem Information; Circuit Failure; Insufficient Device Problem Information

  THE USER WAS RE-IMPLANTED ON (B)(6) 2023.

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

  MAUDE report 21466358 ↗
• MalfunctionDec 9, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS BEING CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

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

  MAUDE report 20875823 ↗
• MalfunctionDec 5, 2024Impedance Problem; Impedance Problem

  AFFECTED CHANNELS HAVE BEEN OBSERVED. THE USER SUFFERS FROM CEREBRAL PALSY AND OFTEN HITS HER HEAD. SHE WAS ALREADY BILATERALLY RE-IMPLANTED IN 2019 FOR THE SAME REASONS. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.

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

  MAUDE report 20851602 ↗
• MalfunctionDec 5, 2024Impedance Problem; Impedance Problem

  AFFECTED CHANNELS HAVE BEEN OBSERVED. THE USER SUFFERS FROM CEREBRAL PALSY AND OFTEN HITS HER HEAD. SHE WAS ALREADY BILATERALLY RE-IMPLANTED IN 2019 FOR THE SAME REASONS. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.

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

  MAUDE report 20851277 ↗
• MalfunctionNov 21, 2024Impedance Problem; Migration; Impedance Problem; Migration

  THE USER HAS NO MORE HEARING SENSATION. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 20746597 ↗
• MalfunctionNov 12, 2024Impedance Problem; Impedance Problem

  THE RECIPIENT'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. FURTHER TECHNICAL CHECKS ARE CONSIDERED. HOWEVER, MED-EL CLINICAL SUPPORT RECOMMENDED RE-IMPLANTATION.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 20661969 ↗

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