Mi1200 SYNCHRONY +STANDARD 09395Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 09008737093952), received between Nov 7, 2017 and Sep 15, 2026 — classified as 41 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Output Problem” (51 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 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Impedance Problem

  Hearing performance with the device was affected. The date of re-implantation has not been scheduled yet.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50770615 ↗
• InjurySep 11, 2026Impedance Problem

  Clinic stated reason for explantation is device failure. The user was re-implanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50731047 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  Device explanted due to infection causing a wound. There was also an electrode dislocation.More information has been requested.

  Patient problems: Bacterial Infection

  MAUDE report 50518473 ↗
• MalfunctionJun 17, 2026Impedance Problem

  THE USER SHOWED AFFECTED CHANNELS DURING IN SITU MEASUREMENTS. RE-IMPLANTATION SURGERY WILL PROBABLY BE REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25533568 ↗
• MalfunctionJun 17, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A FALL. RE-IMPLANTATION IS PLANNED WITHIN THE NEXT 30 DAYS. NO SPECIFIC DATE HAS BEEN SET YET.

  Patient problems: Head Injury

  MAUDE report 25532705 ↗
• MalfunctionJun 15, 2026Impedance Problem

  THE USER WILL BE REIMPLANTED, INFORMATION IS LIMITED AT THE MOMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25499070 ↗
• MalfunctionMay 26, 2026Impedance Problem

  THE USER NO LONGER HAS HEARING BENEFIT WITH THE DEVICE. NO INDICATION OF SPECIFIC INCIDENT OR TRAUMA. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25274734 ↗
• MalfunctionFeb 4, 2026Impedance Problem

  THE USER SHOWED AFFECTED CHANNELS SINCE (B)(6) 2025 AND ALSO NOTICED THAT THE HEARING PERFORMANCE IS AFFECTED. CLINICAL FOLLOW-UP IS ONGOING WITH THE CLINICAL TEAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24258328 ↗
• MalfunctionJan 26, 2026Migration

  THE USER NOTICED A GRADUAL DECLINE IN HEARING WITH THE DEVICE. THE USER REPORTEDLY ALREADY HAD 3 EXTRACOCHLEAR CHANNELS AFTER THE INITIAL IMPLANTATION, AND THE ELECTRODE ARRAY SUBSEQUENTLY MIGRATED FURTHER OUT OF THE COCHLEA. THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176082 ↗
• MalfunctionDec 19, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. CT IMAGING WITH SURGICAL REVIEW FOR POSSIBLE REIMPLANTATION IS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848095 ↗
• MalfunctionDec 4, 2025Impedance Problem; Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713597 ↗
• MalfunctionOct 30, 2025Circuit Failure; Circuit Failure

  DURING THE INITIAL IMPLANTATION PRE-OPERATIVE IN THE BOX MEASUREMENTS COULD NOT BE PERFORMED. TESTING FAILED, AS NO CONNECTION BETWEEN THE TEST COIL AND THE IMPLANT IN THE SEALED PACKAGING COULD BE ESTABLISHED. A BACK-UP DEVICE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23423548 ↗
• MalfunctionOct 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  REPORTEDLY A MALFUNCTION OF THE IMPLANT WAS DETECTED. THE USER WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 23412451 ↗
• MalfunctionSep 29, 2025Impedance Problem; Impedance Problem

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

  Patient problems: Head Injury

  MAUDE report 23166505 ↗
• MalfunctionSep 9, 2025Impedance Problem; Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23001775 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DEVICE WAS EXPLANTED DUE TO INFLAMMATION AND A SKIN FLAP DEFECT OVER THE IMPLANT, WITH THE CLINIC ATTRIBUTING IT TO A SUSPECTED ALLERGIC SKIN REACTION. THE WOUND COMPLETELY HEALED 7 DAYS AFTER EXPLANTATION. SIGNS OF ALLERGY HAVE DISAPPEARED COMPLETELY.

  Patient problems: Inflammation

  MAUDE report 22308177 ↗
• MalfunctionApr 24, 2025Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. A CT AND ANOTHER TECHNICAL CHECK IN 1-2 WEEKS IS CONSIDERED. MOST LIKELY A RE-IMPLANTATION WILL BE NECESSARY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21897102 ↗
• MalfunctionFeb 19, 2025Impedance Problem; Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. ACCORDING TO THE USER'S MOTHER, THE IMPLANT DAMAGE WAS FIRST NOTICED DURING THE FITTING PROCEDURE OF THE SPEECH PROCESSOR ON 07FEB2025. THE USER HAS BEEN REIMPLANTED.

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

  MAUDE report 21410677 ↗
• MalfunctionJan 28, 2025Circuit Failure; Circuit Failure

  SINCE (B)(6) 2024, THE USER REPORTS SUDDEN FLUCTUATIONS IN HEARING (ON/OFF/SILENT), ESPECIALLY IN THE EVENING. THERE HAS BEEN NO ACCIDENT/TRAUMA. EXTERNAL PARTS HAVE BEEN CHECKED AND ARE WORKING PROPERLY. THE USER HAS BEEN RE-IMPLANTED.

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

  MAUDE report 21250749 ↗
• MalfunctionJan 23, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. DURING FITTING THAT FOLLOWED ACTIVATION IT WAS OBSERVED THAT THE USER'S DEVICE IS NOT FUNCTIONING CORRECTLY.

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

  MAUDE report 21217226 ↗
• InjuryJan 9, 2025Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem; Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  THE USER EXPERIENCED HEMATOMA AND EDEMA AT THE IMPLANT SITE TWICE LAST YEAR. INITIALLY, THE CONDITION WAS MANAGED WITH MEDICATION, BUT DURING THE SECOND OCCURRENCE, THE SKIN STARTED TO OPEN, PROMPTING SURGERY ON (B)(6)2023 TO REPOSITION THE IMPLANT AND CLEAR THE INFECTION.

  Patient problems: Tissue Breakdown

  MAUDE report 21110752 ↗
• InjuryDec 27, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER HAS ALREADY EXPERIENCE 2 INFECTIONS IN 2023 AND NOW THE USER EXPERIENCED A RECURRENCE OF INFECTION AND WOUND OPENING AT THE IMPLANT SITE. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Tissue Breakdown

  MAUDE report 21025177 ↗
• MalfunctionOct 28, 2024Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. THE CLINIC IS CONSIDERING REIMPLANTATION.

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

  MAUDE report 20542672 ↗
• MalfunctionSep 9, 2024Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT THE USER HAD NO HEARING SENSATION WITH THE DEVICE AFTER A SEVERE TRAUMA TO THE HEAD. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 20167256 ↗
• MalfunctionSep 5, 2024Impedance Problem; Insufficient Device Problem Information; Impedance Problem; Insufficient Device Problem Information

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED DUE TO A TRAUMA TO THE HEAD THAT OCCURRED ON (B)(6) 2024.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 20143364 ↗

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-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-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