Mi1200 SYNCHRONY PIN +STANDARD 09396Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 09008737093969), received between Jul 9, 2018 and Sep 24, 2026 — classified as 11 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (41 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Impedance Problem

  Affected channels were noticed during in situ measurements. It is not known exactly when the problems began. Possible re-implantation, no data has been scheduled yet.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50879289 ↗
• MalfunctionSep 4, 2026Impedance Problem

  There was a sudden change in hearing sensation with the device. Reimplantation is considered, however no date has been scheduled yet.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50608612 ↗
• MalfunctionAug 22, 2026Impedance Problem

  The user's hearing performance with the device is affected. No date for a revision surgery has been scheduled yet.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50391212 ↗
• MalfunctionJun 15, 2026Impedance Problem

  APPROXIMATELY 1 YEAR AGO THE USER FELL AND HIT HIS HEAD, THE USER STOPPED USING THE IMPLANT AND DIDN'T INFORM THE TEAM UNTIL NOW. REIMPLANTATION IS LIKELY BUT THE CLINIC HAS NOT SCHEDULED A DATE FOR THE SURGERY YET.

  Patient problems: Head Injury

  MAUDE report 25499067 ↗
• MalfunctionMay 13, 2026Impedance Problem

  THE USER HAS REPORTED A SUDDEN LOSS IN HEARING PERFORMANCE WITH THE DEVICE. REIMPLANTATION IS CONSIDERED HOWEVER NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157839 ↗
• MalfunctionApr 16, 2026Impedance Problem

  THE USER REPORTED A SUDDEN LOSS OF HEARING WITH THE DEVICE IN (B)(6) 2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24896607 ↗
• MalfunctionFeb 4, 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 24258372 ↗
• MalfunctionJan 30, 2026Impedance Problem

  DURING THE FIRST FITTING THE CLINIC NOTICED AFFECTED CHANNELS. RE-IMPLANTATION IS CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219740 ↗
• MalfunctionDec 23, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER HAS POOR RESULTS IN REHABILITATION. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875369 ↗
• InjuryDec 19, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER'S MAGNET COULD BE PULLED OUT. A SKIN INFECTION IS SUSPECTED; HOWEVER, INFORMATION IS LIMITED AT THIS TIME. A REVISION SURGERY DUE TO THE SKIN INFECTION WAS PERFORMED AND THE MAGNET WAS REMOVED.

  Patient problems: Skin Tears

  MAUDE report 23848464 ↗
• MalfunctionNov 24, 2025Circuit Failure; Circuit Failure

  THE IMPLANT REPORTEDLY WAS NOT DETECTABLE DURING IN SITU MEASUREMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631255 ↗
• MalfunctionNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTEDLY, ACCORDING TO DATA RETRIEVED FROM MAESTRO 11 ALL CHANNELS WERE DEACTIVATED IN (B)(6) 2025, FOR UNKNOWN REASONS. A REVISION SURGERY WAS PERFORMED TO REPOSITION THE ELECTRODE ANTERIORLY.

  Patient problems: Insufficient Information

  MAUDE report 23508005 ↗
• MalfunctionNov 4, 2025Impedance Problem; Impedance Problem

  THE USER EXPERIENCED A SUDDEN LOSS OF HEARING SENSATION. THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23463362 ↗
• MalfunctionSep 11, 2025Migration; Migration

  THE ELECTRODE WAS NOT INSIDE THE COCHLEA. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23023765 ↗
• MalfunctionJul 22, 2025Impedance Problem; Impedance Problem

  THE USER STOPPED RESPONDING TO SOUNDS 2 WEEKS AGO. RE-IMPLANTATION IS PLANNED, BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563161 ↗
• MalfunctionMar 27, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA TO THE HEAD. RE-IMPLANTATION IS BEING CONSIDERED.

  Patient problems: Head Injury

  MAUDE report 21706477 ↗
• MalfunctionFeb 13, 2025Impedance Problem; Impedance Problem

  THE USER REPORTED NO HEARING SENSATION WITH THE DEVICE. RE-IMPLANTATION IS BEING CONSIDERED BUT WILL NOT BE PERFORMED EARLIER THAN IN TWO TO THREE MONTHS.

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

  MAUDE report 21374484 ↗
• MalfunctionFeb 3, 2025Impedance Problem; Impedance Problem

  THE USER'S DEVICE SHOWED AFFECTED CHANNELS DURING THE FIRST FITTING. THE USER'S FAMILY HAS DENIED ANY TRAUMA OR ACCIDENT. ADDITIONAL MEASUREMENTS HAVE BEEN SCHEDULED, A DATE FOR A POTENTIAL REVISION SURGERY HAS NOT BEEN SCHEDULED YET.

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

  MAUDE report 21294114 ↗
• MalfunctionJan 29, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IMAGING WILL BE PERFORMED AND REVISION SURGERY IS CONSIDERED.

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

  MAUDE report 21263407 ↗
• MalfunctionDec 18, 2024Impedance Problem; Impedance Problem

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

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

  MAUDE report 20961936 ↗
• MalfunctionDec 18, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER REPORTEDLY NOTICED A SUDDEN CHANGE IN HEARING WITH THE DEVICE. DURING ROUTINE FITTING WHEN IN SITU MEASUREMENTS WERE PERFORMED AND SOUND PERCEPTION WAS TESTED IT WAS DETERMINED THAT THE CHILD DOES NOT HEAR. REVISION SURGERY IS CONSIDERED, HOWEVER NO DATE HAS BEENS SCHEDULED YET.

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

  MAUDE report 20961935 ↗
• InjuryDec 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE DEVICE HAS BEEN EXPLANTED. ACCORDING TO THE DEVICE EXPLANT REPORT FORM THE DEVICE WAS EXPOSED AND THE SKIN OVER THE DEVICE WAS NOT INTACT.

  Patient problems: Tissue Breakdown

  MAUDE report 20937634 ↗
• MalfunctionOct 17, 2024Impedance Problem; Impedance Problem

  THE USER EXPERIENCED A SUDDEN CHANGE IN HEARING WITH THE DEVICE IN (B)(6) 2024. THE USER WAS REIMPLANTED IN (B)(6) 2024.

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

  MAUDE report 20469683 ↗
• MalfunctionSep 30, 2024Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. REIMPLANTATION SURGERY IS CONSIDERED.

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

  MAUDE report 20332503 ↗
• MalfunctionSep 30, 2024Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. REIMPLANTATION SURGERY IN 2-3 MONTHS IS CONSIDERED.

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

  MAUDE report 20332499 ↗

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