Mi1200 SYNCHRONY +COMPRESSED 09408Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 09008737094089), received between Sep 10, 2019 and Aug 31, 2026 — classified as 14 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Output Problem” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Impedance Problem

  The user was diagnosed with cochlear malformation. Insertion resistance was encountered during the implantation procedure. The user was reimplanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50516895 ↗
• MalfunctionJan 30, 2026Impedance Problem

  DURING IMPLANTATION SURGERY IN SITU MEASUREMENTS REPORTEDLY SHOWED AFFECTED CHANNELS. A BACK-UP IMPLANT WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219747 ↗
• MalfunctionNov 24, 2025Impedance Problem; Impedance Problem

  THE RECIPIENT HAS NOT WORN AUDIO PROCESSORS BILATERALLY SINCE 2019 AND WAS NOW ABOUT TO BE REACTIVATED AGAIN. FURTHER PROCEEDINGS ARE CURRENTLY UNKNOWN.

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

  MAUDE report 23632259 ↗
• MalfunctionAug 18, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. FURTHER PROCEEDINGS ARE CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827581 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CHILD IS BILATERALLY IMPLANTED AND HAD MENINGITIS MULTIPLE TIMES, SO IT WAS DECIDED TO REMOVE THE IMPLANT ON THE LEFT SIDE. THE USER WAS EXPLANTED APPROXIMATELY ON (B)(6) 2024. AFTER THE IMPLANT WAS REMOVED, THE CHILD NO LONGER HAD ANY CASES OF MENINGITIS.

  Patient problems: Meningitis

  MAUDE report 22229191 ↗
• MalfunctionJun 5, 2025No Device Output; No Device Output

  THE DEVICE WAS RECEIVED AT THE MANUFACTURER. ACCORDING TO ADDITIONAL INFORMATION THE CAUSE OF THE EXPLANTATION WAS A TRAUMA. A GATE FELL ON THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22147873 ↗
• InjuryFeb 26, 2024Microbial Contamination of Device; Microbial Contamination of Device

  THE EXPLANTED DEVICE HAS BEEN RECEIVED. ACCORDING TO THE DEVICE EXPLANT REPORT FORM THE USER HAD A PNEUMOCOCCAL MENINGITIS WHERE THE ELECTRODE ARRAY ACTED AS BACTERIAL CONDUCTOR TO THE INTRACRANIAL AREA. REPORTEDLY, THE USER WAS NOT IMPLANTED WITH A NEW DEVICE. FURTHER INFORMATION HAS BEEN REPEATEDLY REQUESTED, BUT HAS NOT BEEN RECEIVED.

  Patient problems: Meningitis

  MAUDE report 18778167 ↗
• InjuryDec 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER REPORTEDLY HAD 3 INSTANCES OF MENINGITIS WITH CSF GUSHER. FURTHER PROCEEDINGS ARE CURRENTLY UNKNOWN.

  Patient problems: Meningitis

  MAUDE report 18409308 ↗
• InjuryAug 8, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE USER REPORTEDLY HAS AN INFECTION AND AN ABSCESS NEAR THE SITE OF THE IMPLANT. THE INFECTION HAS REPORTEDLY SPREAD TO THE LEVEL OF THE IMPLANT. IN (B)(6) 2023, GRANULATION APPEARED AND THE USER'S PARENTS SOUGHT MEDICAL ASSISTANCE EVERY 2-4 WEEKS. ON (B)(6) AN ABSCESS APPEARED AND THE CLINIC PRESCRIBED ANTIBIOTICS TO AVOID A SECOND SURGERY. BETWEEN (B)(6) AND (B)(6), THE ABSCESS BROKE AND THE CLINIC AND THE PARENTS DISCUSSED REMOVING THE DEVICE. THE DEVICE WAS EXPLANTED ON (B)(6) 2023.

  Patient problems: Bacterial Infection

  MAUDE report 17481034 ↗
• MalfunctionJun 30, 2023Migration; Migration

  THE USER WAS RE-IMPLANTED. PER EXPLANTATION REPORT THERE WERE APPROX. 8 EXTRA-COCHLEAR CHANNELS.

  Patient problems: Failure of Implant

  MAUDE report 17236616 ↗
• MalfunctionMay 10, 2023Impedance Problem; Impedance Problem

  THE USER_S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.THE USER WAS REIMPLANTED ON (B)(6)2023

  Patient problems: Failure of Implant

  MAUDE report 16902351 ↗
• InjuryOct 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED THAT THE DEVICE HAS BEEN EXPLANTED. THE USER HAD 3 POST-OPERATIVE EPISODES OF MENINGITIS ((B)(6) 2022) FOR WHICH HE HAD TO BE HOSPITALIZED EACH TIME AND TREATED ACCORDINGLY. IT WAS THEN DECIDED TO PERFORM REVISION SURGERY AND TO REMOVE THE DEVICE. REPORTEDLY, A CT SCAN SHOWED AN ANOMALY (COMMON CAVITY). AN TRANSORBITAL X-RAY SHOWED THE ELECTRODE INSIDE THE COCHLEA.

  Patient problems: Meningitis

  MAUDE report 15689358 ↗
• MalfunctionApr 15, 2022Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IN SITU TESTING SHOWED AFFECTED CHANNELS. REIMPLANTATION IS BEING DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 14118052 ↗
• MalfunctionFeb 3, 2022Output Problem; Output Problem

  IN SITU MEASUREMENTS SHOWED AFFECTED CHANNELS. THE USER DID NOT HAVE GOOD BENEFIT WITH THE DEVICE BEFORE. THE USER HAS HYPOPLASIA ON BOTH SIDES. REPORTEDLY THE USER MAY HAVE SUFFERED A TRAUMA. REIMPLANTATION OR EXPLANTATION SURGERY IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 13438908 ↗
• InjuryJul 28, 2021Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. NO ACCIDENT OR TRAUMA HAS BEEN REPORTED BUT PER PARENTS THE USER IS WOBBLY ON HER FEET. RECIPIENT WAS REIMPLANTED ON (B)(6) 2021. THIS REPORT REFERS TO 9710014-2020-00656. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Failure of Implant

  MAUDE report 12237464 ↗
• InjuryMay 7, 2021Output Problem; Output Problem

  THE USERS PERFORMANCE WITH THE DEVICE IS AFFECTED. RE-IMPLANTATION IS PLANNED BUT NO DATE HAS BEEN MADE AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 11788601 ↗
• MalfunctionApr 22, 2021Output Problem; Output Problem

  THE USER_S PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 11705527 ↗
• InjuryNov 12, 2020Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. NO ACCIDENT OR TRAUMA HAS BEEN REPORTED BUT PER PARENTS THE USER IS WOBBLY ON HER FEET.

  Patient problems: Failure of Implant

  MAUDE report 10827998 ↗
• InjuryOct 14, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE RECIPIENT WAS PLANNED TO BE EXPLANTED DUE TO ELECTRODE LEAD EXTRUSION THROUGH THE TYMPANIC MEMBRANE AND NON-USE. THE RECIPIENT NEVER HAD BENEFIT FROM THE DEVICE DUE TO CYSTIC COCHLEA DEFORMITY AND COCHLEAR NERVE DEFICIENCY. EXPECTATIONS AT IMPLANTATION WERE MINIMAL BECAUSE OF THESE CONDITIONS. THE CLINIC HAD BEEN PLANNING EXPLANTATION FOR A WHILE. NO NEW DEVICE WILL BE IMPLANTED. THE DEVICE WAS EXPLANTED (B)(6) 2020.

  Patient problems: Skin Tears

  MAUDE report 10676268 ↗
• InjurySep 29, 2020Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE ELECTRODE LEAD EXTRUDED THROUGH THE TYMPANIC MEMBRANE. THE DEVICE WAS EXPLANTED ON (B)(6) 2020.

  Patient problems: Failure of Implant; Tissue Breakdown

  MAUDE report 10599679 ↗
• InjuryAug 5, 2020Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A SEVERE LEFT-SIDED HEAD TRAUMA. THE USER WILL BE RE-IMPLANTED ON THE (B)(6).

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 10366104 ↗
• InjurySep 25, 2019Output Problem; Output Problem

  REPORTEDLY THE SOUND WITH THE DEVICE BECAME TO SOFT STARTING IN (B)(6) 2019. PRIOR THE RECIPIENT WAS DOING WELL WITH PERFORMANCE INCREASING OVER TIME. THERE HAVE BEEN NO RECENT CHANGES IN HEALTH, BUMPS ON THE HEAD OR PAIN. ADDITIONALLY, THERE WAS NO SWELLING OR REDNESS AT IMPLANT SITE. THERE ARE NO CONCERNS WITH HIS HEARING ON THE CONTRALATERAL EAR. RE-IMPLANTATION TOOK PLACE ON (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 9114655 ↗
• MalfunctionSep 23, 2019Output Problem; Output Problem

  WHEN THE USER ATTENDED A FITTING SESSION SHE REPORTED THAT HEARING PERFORMANCE WITH THE DEVICE HAD CHANGED. NO CLEAR SPECIFICATION ON REDUCED PERFORMANCE WAS MENTIONED. THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 9107446 ↗
• InjurySep 10, 2019Output Problem; Output Problem

  REPORTEDLY THE SOUND WITH THE DEVICE BECAME TOO SOFT STARTING IN AUGUST 2019. PRIOR THE RECIPIENT WAS DOING WELL WITH PERFORMANCE INCREASING OVER TIME. THE RECIPIENT HAD 6 CHANNELS LEFT FOR STIMULATION, BUT DURING MOST COMFORTABLE LOUDNESS MEASURES THE REMAINING CHANNELS (1-6) CAUSED FACIAL NERVE STIMULATION AND THE LEVELS WERE STILL TOO SOFT. TRIPHASIC STIMULATION AND RE-FITTINGS DID NOT RESOLVE STIMULATION OF THE FACIAL NERVE.RE-IMPLANTATION TOOK PLACE ON (B)(6), 2019. ONE WEEK POST ACTIVATION THERE WAS AN IMPROVEMENT IN AIDED THRESHOLDS AND THE USER REPORTED IMPROVED CLARITY. THE USER REPORTED THE SOUND WAS INITIALLY TOO SOFT BUT AFTER MAPPING AN IMPROVEMENT IN LOUDNESS AND CLARITY WAS REPORTED.

  Patient problems: Failure of Implant; Undesired Nerve Stimulation

  MAUDE report 8978934 ↗

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