Mi1210 SYNCHRONY ST +STANDARD 33182Recalls & reported problems

Summary

The FDA's MAUDE database contains 321 adverse event reports that list this exact device (DI 09008737331825), received between Jul 18, 2018 and May 5, 2026 — classified as 106 injuries, 215 malfunctions.

The most frequently reported specific device problem is “Output Problem” (200 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 321 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Impedance Problem

  FOLLOWING A TRAUMA TO THE HEAD, HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. RE-IMPLANTATION IS PLANNED, BUT NO DATE HAS BEEN DISCLOSED.

  Patient problems: Head Injury

  MAUDE report 25078336 ↗
• MalfunctionApr 27, 2026Migration

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

  Patient problems: Insufficient Information

  MAUDE report 24994143 ↗
• MalfunctionApr 13, 2026Impedance Problem

  THE USER SUFFERED A TRAUMA AND AFTER THIS THE HEARING WITH THE DEVICE WORSENED.

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

  MAUDE report 24854251 ↗
• MalfunctionMar 18, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628808 ↗
• MalfunctionFeb 4, 2026Impedance Problem

  THE USER HIT HIS HEAD ON A CABINET, BREAKING HIS EXTERNAL DEVICE AND CAME IN FOR A CHECK UP ON (B)(6) 2026.

  Patient problems: Head Injury

  MAUDE report 24256533 ↗
• MalfunctionJan 21, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER AN IMPACT TO THE IMPLANT SITE. RE-IMPLANTATION DONE ON (B)(6) 2026.

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

  MAUDE report 24127807 ↗
• MalfunctionDec 17, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA. THE USER WAS REIMPLANTED.

  Patient problems: Head Injury

  MAUDE report 23828743 ↗
• MalfunctionDec 17, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS SUDDENLY AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828726 ↗
• MalfunctionOct 7, 2025Impedance Problem; Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23231189 ↗
• MalfunctionSep 19, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 23097083 ↗
• InjurySep 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE EXPLANTED DEVICE WAS RECEIVED FOR INVESTIGATION. THE USER WAS RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 22989762 ↗
• MalfunctionAug 7, 2025Impedance Problem; Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735615 ↗
• MalfunctionAug 7, 2025Impedance Problem; Impedance Problem

  THE USER'S PARENTS REPORTED THAT THE CHILD SUDDENLY STOPPED HEARING AFTER SEVERAL TRAUMAS TO THE HEAD.

  Patient problems: Head Injury

  MAUDE report 22735613 ↗
• MalfunctionAug 4, 2025Circuit Failure; Circuit Failure

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THERE WAS NO REDNESS OR SWELLING SEEN OVER THE IMPLANT AREA. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22699166 ↗
• MalfunctionJun 4, 2025Impedance Problem; Impedance Problem

  INFORMATION WAS RECEIVED THAT THE DEVICE HAS BEEN EXPLANTED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22138987 ↗
• MalfunctionMay 19, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE CHILD STOPPED RESPONDING TO SOUNDS. THERE WERE NO REPORTS OF ANY ACCIDENTS OR TRAUMA, HIGH-GRADE FEVER, SWELLING OR REDNESS AT THE IMPLANT SITE. NO OTHER MEDICAL PROBLEMS WERE REPORTED. RE-IMPLANTATION IS BEING CONSIDERED, BUT NO DATE HAS YET BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22041640 ↗
• MalfunctionApr 30, 2025Circuit Failure; Circuit Failure

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

  Patient problems: Head Injury

  MAUDE report 21932650 ↗
• MalfunctionApr 28, 2025Impedance Problem; Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21916365 ↗
• MalfunctionApr 23, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER_S HEARING WAS BADLY DAMAGED IN A CAR ACCIDENT AND SO SHE WAS IMPLANTED WITH A COCHLEAR IMPLANT IN 2023. SHE HAS HAD GOOD HEARING BENEFIT SINCE THEN AND HER HEARING DEVELOPMENT HAS PROGRESSED NORMALLY. LATELY, THE USER HAS COMPLAINED THAT SHE HAS NO HEARING SENSATION ANY LONGER. THE BATTERY OF HER AUDIO PROCESSOR WAS CHANGED, BUT THIS DID NOT RESOLVE THE ISSUE. NO CHANGE IN MEDICATION, NO SIGNIFICANT MEDICAL HISTORY AND NO REDNESS OR SWELLING WERE NOTICED. THE WOUND HEALED COMPLETELY. FURTHER THERE WAS NO INFECTION AND NO PAIN AROUND THE IMPLANT. FURTHER TECHNICAL CHECKS ARE CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887741 ↗
• MalfunctionApr 4, 2025Circuit Failure; Migration; Circuit Failure; Migration

  REPORTEDLY THE POSITION OF THE IMPLANT BODY CHANGED OVER TIME. RECURRING SWELLING AND INFECTIONS OVER SEVERAL YEARS ARE REPORTED. THE USER WAS HOSPITALIZED SEVERAL TIMES DUE TO INFLAMMATION OF THE OPERATED EAR. HE WAS TREATED WITH ANTIBIOTICS ACCORDING TO THE MICROBIOLOGICAL FINDINGS. GRANULATIONS WERE FOUND ON THE BACK (POSTERIOR) WALL OF THE EAR CANAL (WHICH WERE PREVIOUSLY CONFIRMED HISTOPATHOLOGICALLY). ALSO THE OPERATION IN (B)(6) 2024 (INCISIO ABSCESSUS RETROAURICULARIS L. SON.) WAS DONE DUE TO THE RECURRING SWELLING. A CT SCAN OF THE TEMPORAL BONE WAS PERFORMED AS WELL. A BIOPSY WAS TAKEN AND THE WOUND WAS SWABBED. THE CHILD WAS DISCHARGED ON 04-MAR-2024 IN GOOD GENERAL CONDITION. GRANULATIONS AND SMALLER PIECES OF BONE ARE PRESENT IN THE MASTOID CAVITY. REPORTEDLY, THE POSITION OF THE ELECTRODE IS CORRECT. FINALLY, THE DEVICE WAS EXPLANTED AS THE USER'S PARENTS DID NOT WANT THE CHILD TO HAVE A REPOSITIONING SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 21777901 ↗
• MalfunctionMar 25, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. ACCORDING TO THE USER_S PARENTS, THE CHILD WAS HIT ON THE HEAD AREA BEGINNING OF (B)(6) 2025 AND AFTERWARDS THEY NOTICED THAT THE CHILD STOPPED RESPONDING TO SOUNDS. THE DEVICE WAS EXPLANTED.

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

  MAUDE report 21685729 ↗
• MalfunctionMar 18, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS BEING CONSIDERED.

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

  MAUDE report 21628779 ↗
• MalfunctionMar 12, 2025Impedance Problem; Impedance Problem

  THE USER ALWAYS HAD A GOOD HEARING PERFORMANCE WITH THE DEVICE, BUT SUDDENLY THE HEARING SENSATION STOPPED. RE-IMPLANTATION IS BEING CONSIDERED.

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

  MAUDE report 21581833 ↗
• MalfunctionMar 12, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE CHILD SUDDENLY STOPPED RESPONDING TO SOUNDS. NO HIGH GRADE FEVER, NO SWELLING OR REDNESS AROUND THE IMPLANT AREA AND NO TRAUMA OR INJURY WAS REPORTED. NO ABNORMALITIES WERE FOUND ON X-RAY IMAGING. THE EXTERNAL DEVICE WAS CHECKED AND WAS FOUND TO BE WORKING PROPERLY. RE-IMPLANTATION IS BEING CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

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

  MAUDE report 21581831 ↗
• MalfunctionMar 7, 2025Impedance Problem; Impedance Problem

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

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

  MAUDE report 21545414 ↗

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-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-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