Mi1200 SYNCHRONY PIN +FLEXsoft 09403Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 09008737094034), received between Sep 11, 2018 and Apr 15, 2026 — classified as 16 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Output Problem” (9 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Impedance Problem

  FOLLOWING A HEAD TRAUMA, HIGH IMPEDANCES WERE REPORTEDLY OBSERVED ON ALL CHANNELS. THE USER WAS REIMPLANTED ON (B)(6) 2026.

  Patient problems: Head Injury

  MAUDE report 24885723 ↗
• MalfunctionFeb 26, 2026Impedance Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452103 ↗
• MalfunctionJan 28, 2026Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. A CT SCAN IS SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197505 ↗
• MalfunctionAug 26, 2025Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. FOLLOWING IMPLANTATION SURGERY, TWO EXTRACOCHLEAR CHANNELS WERE REPORTEDLY INITIALLY IDENTIFIED. SUBSEQUENT IMAGING REVEALED THREE EXTRACOCHLEAR ELECTRODES AND ONE ELECTRODE LOCATED AT THE ROUND WINDOW. RE-INSERTION IS CONSIDERED. PROBABLY RE-INSERTION AND INITIAL IMPLANTATION ON THE CONTRALATERAL SIDE WILL BE DONE TOGETHER. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Pain

  MAUDE report 22892966 ↗
• MalfunctionJul 28, 2025Impedance Problem; Impedance Problem

  AFFECTED CHANNELS WERE NOTICED DURING IN SITU MEASUREMENTS. RE-IMPLANTATION IS PLANNED IN (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22629218 ↗
• InjuryJun 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  TWO YEARS AFTER IMPLANTATION SWELLING OCCURED AROUND THE IMPLANT SIDE. THE COIL SITE BECAME EXPOSED, SO THE DEVICE WAS EXPLANTED ON THE (B)(6) 2025.

  Patient problems: Tissue Breakdown

  MAUDE report 22318193 ↗
• MalfunctionOct 31, 2024Loose or Intermittent Connection; Impedance Problem; Loose or Intermittent Connection; Impedance Problem

  AFTER YAWNING, THE USER NOTICED THAT THE HEARING PERFORMANCE WITH THE DEVICE ON THE RIGHT EAR BECAME INTERMITTENT. RE-IMPLANTATION SURGERY IS SCHEDULED FOR (B)(6) 2025.

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

  MAUDE report 20576263 ↗
• MalfunctionMay 29, 2024Circuit Failure; Circuit Failure

  THE CLINIC INFORMED THE FIELD THAT THE USER UNDERWENT EXPLANTATION DUE TO THE LACK OF SUBJECTIVE BENEFIT FROM THE IMPLANT. THE USER WAS EXPLANTED ON (B)(6) 2023. THE USER WILL NOT BE REIMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 19415197 ↗
• MalfunctionMay 8, 2024Migration; Migration

  THE USER HAS BEEN RE-IMPLANTED IN 2021 DUE TO AN ELECTRODE MIGRATION. THE EXPLANTED DEVICE WILL NOT BE RETURNED TO HQ.

  Patient problems: Failure of Implant

  MAUDE report 19269182 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT EXPERIENCED SKIN NECROSIS OVER THE IMPLANT MAGNET AND PREVIOUSLY HAD SKIN IRRITATION WITH THE MAGNET IN THE LAST SEVERAL MONTHS. REPORTEDLY THE IMPLANT IS WORKING WITHOUT FAILURE. THE EXPLANTATION SURGERY IS SCHEDULED FOR (B)(6) 2024.

  Patient problems: Necrosis

  MAUDE report 18957623 ↗
• MalfunctionJun 13, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING WITH THE DEVICE WAS AFFECTED. THE USER REPORTED A SUDDEN CHANGE IN HEARING WITH THE DEVICE. THE USER WAS REIMPLANTED ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 17115864 ↗
• InjuryJun 9, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE ELECTRODE LEAD EXTRUDED INTO THE EXTERNAL AUDITORY CANAL (EAC). ON (B)(6) 2023, THE CLINIC CONDUCTED A REVISION SURGERY TO REPAIR THE EAC. THE DEVICE REMAINS IMPLANTED AND IN USE AND THE USER IS REPORTEDLY ABLE TO USE THE DEVICE AGAIN.

  Patient problems: Skin Tears

  MAUDE report 17096352 ↗
• InjuryMay 17, 2023Device 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 IMPLANT HOUSING IS EXPOSED BEHIND THE USER'S RIGHT EAR. THE USER WAS REIMPLANTED ON (B)(6) 2023.

  Patient problems: Skin Tears; Unspecified Infection

  MAUDE report 16945429 ↗
• MalfunctionJan 30, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED. REPORTEDLY IT DETERIORATED SUDDENLY IN DECEMBER 2022. IT IS UNKNOWN WHETHER A TRAUMA OR ACCIDENT HAPPENED. THE USER SHOWED GOOD BENEFIT WITH THE DEVICE BEFORE.

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

  MAUDE report 16262490 ↗
• MalfunctionMar 14, 2022Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER COMPLAINT THAT THE AUDIO WITH THE DEVICE IS TOO LOW. THE CLINIC NOTICED SWELLING LOCATED ON THE LEFT SIDE OF THE HEAD, NEAR THE RECEIVER/STIMULATOR IN (B)(6) 2022. IMAGING WILL BE PERFORMED, REVISION SURGERY IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 13757748 ↗
• MalfunctionDec 14, 2021Impedance Problem; Output Problem; Impedance Problem; Output Problem

  DURING A CHECKUP AFFECTED CHANNELS WERE NOTICED, IT'S UNKNOWN IF THE USER HAD A TRAUMA. RE-IMPLANTATION SURGERY IS CONSIDERED BUT NO DATE HAS BEEN SET.

  Patient problems: Failure of Implant

  MAUDE report 12992397 ↗
• InjuryJan 14, 2021Migration; Migration

  THE USER WAS INVOLVED IN A CAR ACCIDENT IN WHICH HE HIT HIS HEAD ON THE SIDE WINDOW OF HIS CAR DIRECTLY OVER THE IMPLANT IN (B)(6) 2019. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 11169050 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECIPIENT REPORTED SWELLING AT THE IMPLANT SITE SINCE THE DEVICE WAS IMPLANTED ON (B)(6) 2019. THE USER WAS EXAMINED BY PHYSICIAN ABOUT OOZING OF PUS FROM THE INCISION AREA ON (B)(6) 2019. IT WAS SUSPECTED THAT THERE WAS AN INFECTION. RECIPIENT HAS BEEN UNABLE TO USE THE DEVICE SINCE THE APPOINTMENT ON (B)(6) 2019. ACCORDING TO INFORMATION RECEIVED ON THE (B)(6) 2019, THE INFECTION WAS UNDER CONTROL. IT IS BELIEVED THAT THE USER EXPERIENCED A CONTACT DERMATITIS FROM THE EXTERNAL EQUIPMENT THAT SPREAD INTERNALLY. AS OF INFORMATION RECEIVED IN MARCH 2020 THE INFECTION DID FLARE UP AGAIN AND THEREFORE THE USER WAS EXPLANTED ON THE (B)(6) 2020. THIS REPORT REFERS TO 9710014-2020-00170. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Bacterial Infection

  MAUDE report 11160309 ↗
• InjuryDec 24, 2020Output Problem; Output Problem

  THE USER REPORTED FALLING AND HITTING HER HEAD AT HOME, RESULTING IN 6 STITCHES ON HER HEAD JUST INFERIOR TO HER INTERNAL DEVICE. THE USER SUDDENLY LOST HEARING BENEFIT WITH THE DEVICE.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 11071237 ↗
• MalfunctionSep 29, 2020Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. REPORTEDLY THE PROBLEMS WITH THE DEVICE STARTED IN APRIL 2019. THE USER HAS BEEN REIMPLANTED ON (B)(6) 2022 .

  Patient problems: Failure of Implant

  MAUDE report 10599060 ↗
• InjuryAug 26, 2020Output Problem; Output Problem

  IN SITU MEASUREMENTS SHOWED AFFECTED RESULTS. HEARING PERFORMANCE IS AFFECTED.

  Patient problems: Failure of Implant

  MAUDE report 10452822 ↗
• InjuryJul 7, 2020Migration; Migration

  THE RIGHT IMPLANT HAS REPORTEDLY SLIPPED DOWN. MOVEMENT WAS FIRST DOCUMENTED ON THE (B)(6) 2019. THE COIL TOUCHED THE PROCESSOR AND THEREFORE THE USER COULD ONLY USE THE SINGLE UNIT PROCESSOR. HOWEVER, ALSO THAT TOUCHED THE PINNA AND GOT PUSHED OFF. THEREFORE, THE USER HAD TO USE THE SONNET WITH IT OVERLAPPING THE COIL. THE USER HAD THE DEVICE RE-POSITIONED ON (B)(6) 2020. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10238285 ↗
• InjuryJun 8, 2020Migration; Migration

  THE RIGHT IMPLANT HAS REPORTEDLY SLIPPED DOWN. MOVEMENT WAS FIRST DOCUMENTED ON THE (B)(6) 2019. THE USER HAD THE DEVICE SUCCESSFULLY RE-POSITIONED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10127314 ↗
• InjuryMar 11, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  RECIPIENT REPORTED SWELLING AT THE IMPLANT SITE SINCE THE DEVICE WAS IMPLANTED ON (B)(6) 2019. HE WAS EXAMINED BY PHYSICIAN ABOUT OOZING OF PUS FROM THE INCISION AREA ON (B)(6) 2019. IT WAS SUSPECTED THAT THERE WAS AN INFECTION. ACCORDING TO INFORMATION RECEIVED ON THE NOVEMBER 21, 2019, THE INFECTION WAS UNDER CONTROL. IT IS BELIEVED THAT THE USER EXPERIENCED A CONTACT DERMATITIS FROM THE EXTERNAL EQUIPMENT THAT SPREAD INTERNALLY. THE USER HAS STARTED USING HIS DEVICE AGAIN. AS OF INFORMATION RECEIVED ON THE 9TH MARCH 2020 THE INFECTION DID FLARE UP AGAIN AND THEREFORE THE USER WILL BE EXPLANTED.

  Patient problems: Post Operative Wound Infection; Skin Tears; Unspecified Infection

  MAUDE report 9817564 ↗
• InjuryDec 17, 2019Output Problem; Output Problem

  THE USER FELL AND HIT HIS HEAD OVER THE RIGHT IMPLANTED SIDE, CAUSING THE USER TO BLEED. BEFORE THE TRAUMA THE USER HAD HEARING SENSATION WITH THE DEVICE AND WAS MAKING PROGRESS.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 9479038 ↗

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
• 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. Mi100