Mi1250 SYNCHRONY 2 PIN FLEX28 36681Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 09008737366810), received between Jun 8, 2020 and May 6, 2026 — classified as 10 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Migration” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  THE USER HAD A SKIN INJURY BEHIND THE EAR IN THE FORM OF TWO ROUND CIRCLES. THE STITCHES FROM THE IMPLANTATION HAD BECOME INFECTED AS WELL. THE USER HAS BEEN EXPLANTED ON (B)(6) 2026. THE REIMPLANTATION IS SCHEDULED IN 8 WEEKS.

  Patient problems: Necrosis; Skin Infection

  MAUDE report 25093596 ↗
• MalfunctionApr 13, 2026Impedance Problem

  THE DEVICE HAS BEEN EXPLANTED DUE TO HIGH IMPEDANCES ON 7 CHANNELS. USER WAS RE-IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24856197 ↗
• MalfunctionSep 11, 2025Impedance Problem; Impedance Problem

  THE USER RECENTLY BEGAN EXPERIENCING DISCOMFORT WITH SOUND. RE-IMPLANTATION IS CONSIDERED.

  Patient problems: Discomfort

  MAUDE report 23023766 ↗
• MalfunctionJul 14, 2025Impedance Problem; Impedance Problem

  OPERATING ROOM CONTACTED MED-EL AFTER EXPLANTATION. DESPITE REQUESTED, NO FURTHER INFORMATION ON REASON FOR EXPLANTATION WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22492949 ↗
• InjuryFeb 10, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER HAS ONGOING ISSUES WITH THE DEVICE. THE USER SUFFERS FROM SWELLING AND TENDERNESS OVER THE LEFT IMPLANT SITE THAT PERSISTED DESPITE MEDICAL MANAGEMENT. IT WAS RECOMMENDED TO PROCEED TO THE OR FOR INCISION AND DRAINAGE OF LEFT SCALP SEROMA WITH DOXYCYCLINE WOUND IRRIGATION ON (B)(6) 2024. INTRAOPERATIVE CULTURES REVEALED NO GROWTH. THE USER WAS LAST SEEN IN THE CLINIC ON (B)(6) 2024. SKIN IRRITATION AT THE IMPLANT SITE WITH VERY SUPERFICIAL HARDWARE WAS OBSERVED. IT WAS RECOMMENDED TO USE BACTROBAN AND TO STOP USING THE AUDIO PROCESSOR. AT THE MOST RECENT VISIT, CONCERNS REGARDING A POTENTIAL INFECTED IMPLANT EXTRUSION WERE DISCUSSED. EXPLANTATION SURGERY IS SCHEDULED FOR (B)(6) 2025. REIMPLANTATION IS PLANNED 3 MONTHS POST OP IN ORDER TO ALLOW THE SITE TO HEAL. THIS REPORT REFERS TO 9710014-2025-00114. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Tissue Breakdown

  MAUDE report 21341508 ↗
• InjuryDec 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER REPORTEDLY HIT HER HEAD CAUSING A LARGE HAEMATOMA AROUND THE SITE OF THE IMPLANT. THE USER WAS REIMPLANTED A FEW WEEKS LATER ON (B)(6) 2024.

  Patient problems: Hematoma

  MAUDE report 21010237 ↗
• MalfunctionNov 25, 2024Impedance Problem; Migration; Impedance Problem; Migration

  THE USER REPORTED A CHANGE IN HEARING WHEN USING THE DEVICE. THE USER WAS RE-IMPLANTED. ACCORDING TO THE EXPLANT REPORT FORM, 9 ELECTRODE WERE FOUND EXTRA-COCHLEA AT EXPLANTATION.

  Patient problems: Failure of Implant

  MAUDE report 20773144 ↗
• MalfunctionOct 7, 2024Impedance Problem; Impedance Problem

  THE USER HAS BEEN EXPERIENCING A DECREASE IN THE HEARING PERFORMANCE OF THE DEVICE FOR A COUPLE OF MONTHS. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 20382244 ↗
• MalfunctionDec 20, 2023Circuit Failure; No Device Output; Circuit Failure; No Device Output

  HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. TWO WEEKS AGO, THE USER WAS WATCHING TV WITHOUT THE PROCESSOR ON. HE BEGAN HEARING A LOW RUMBLING SOUND; HE EXPLAINED THE SOUND AS A HUMMING/WHIRRING SOUND THAT A MACHINE WOULD MAKE IF ROTATING. HE IMMEDIATELY WENT TO PUT THE PROCESSOR ON HIS HEAD AND THE SOUND WAS VERY LOUD AND HEADACHE INDUCING. THE HEADACHE WENT AWAY AFTER A FEW MINUTES OF REMOVING THE PROCESSOR. THE USER DID NOT WEAR THE PROCESSOR AGAIN UNTIL LAST WEEK. AT THIS TIME, HE SAW HIS AUD WHO TURNED EVERYTHING DOWN UNTIL IT WAS AT A LEVEL HE COULD TOLERATE. THE USER HAS BEEN WEARING IT LIKE THIS FOR THE LAST WEEK BUT PERCEIVES NO BENEFIT WITH THE PROCESSOR TURNED TO THIS LEVEL.

  Patient problems: Failure of Implant

  MAUDE report 18362502 ↗
• MalfunctionOct 25, 2023Migration; Migration

  INCOMPLETE INSERTION AT TIME OF SURGERY WITH PROGRESSIVELY POORER PERFORMANCE OVER TIME. AT MOST RECENT CLINICAL VISIT, 5 CHANNELS WERE DEACTIVATED. THE USER HAS BEEN RE-IMPLANTED. THERE WAS SIGNIFICANT OSSIFICATION NOTED AND THE BASAL TURN OF THE COCHLEA WAS DRILLED TO ACCOMMODATE THE NEW ELECTRODE.

  Patient problems: Failure of Implant

  MAUDE report 18001821 ↗
• MalfunctionJul 4, 2022Migration; Migration

  THE IMPLANT HOUSING APPEARS TO HAVE MOVED OVER TIME. PICTURES SHOWED THAT THE IMPLANT HAS SHIFTED TOWARDS THE PINNA AFTER SURGERY. A FOLLOW-UP INTEGRITY TEST HAS BEEN SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 14905658 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER WAS REPORTEDLY EXPLANTED DUE TO SEVERAL MEDICAL ISSUES. THE USER WILL NOT BE RE-IMPLANTED.

  Patient problems: Meningitis

  MAUDE report 14487814 ↗
• MalfunctionMar 7, 2022Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A TRAUMA TO THE HEAD. THE ACCIDENT OCCURRED IN (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 13678157 ↗
• InjuryOct 4, 2021Migration; Migration

  THE USER'S INTERNAL DEVICE HAS SHIFTED SINCE SURGERY, CAUSING THE EXTERNAL PROCESSOR TO NO LONGER SIT APPROPRIATELY ON HER EAR. THE RECIPIENT COULD NOT WEAR THE AUDIO PROCESSOR (SONNET 2 OR RONDO 3) WITHOUT IT NOW HITTING THE GLASSES AND WITHOUT DISCOMFORT. A REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THE IMPLANT HOUSING MIGRATED AND INITIALLY THE SURGEON INTENDED TO MOVE THE SAME DEVICE BACK INTO POSITION. WHILE DISSECTING TISSUE AWAY FROM THE LEAD, THE ARRAY WAS INADVERTENTLY PULLED OUT OF THE COCHLEA AND SO A NEW IMPLANT WAS USED.

  Patient problems: Failure of Implant

  MAUDE report 12566982 ↗
• InjuryAug 12, 2021Migration; Migration

  THE USER'S INTERNAL DEVICE HAS SHIFTED SINCE SURGERY, CAUSING THE EXTERNAL PROCESSOR TO NO LONGER SIT APPROPRIATELY ON HER EAR. THE RECIPIENT COULD NOT WEAR THE AUDIO PROCESSOR (SONNET 2 OR RONDO 3) WITHOUT IT NOW HITTING THE GLASSES AND WITHOUT DISCOMFORT. A REVISION SURGERY TOOK PLACE ON (B)(6) 2021. THE IMPLANT HOUSING MIGRATED AND INITIALLY THE SURGEON INTENDED TO MOVE THE SAME DEVICE BACK INTO POSITION. WHILE DISSECTING TISSUE AWAY FROM THE LEAD, THE ARRAY WAS INADVERTENTLY PULLED OUT OF THE COCHLEA AND SO A NEW IMPLANT WAS USED.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12312063 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN INFECTION STARTED 3 WEEKS AFTER IMPLANTATION. ACCORDING TO THE DEVICE EXPLANTATION FORM THERE WAS A (B)(6) INFECTION WHICH CAUSED SKIN BREAKDOWN, NAMELY THE USER DEVELOPED AN (B)(6) INFECTION POST-OPERATIVELY. THIS WAS LOCATED ALONG THE INCISION LINE; THERE WAS A SMALL PORTION OF POSTAURICULAR INCISION THAT WAS OPEN BUT SKIN OVERLYING THE DEVICE WAS INTACT. THE RECIPIENT WAS EXPLANTED AND WILL BE RE-IMPLANTED AT A LATER DATE.

  Patient problems: Bacterial Infection

  MAUDE report 11824076 ↗
• InjuryMay 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS A STAPHYLOCOCCUS INFECTION WHICH CAUSED SKIN BREAKDOWN. THE DEVICE WAS EXPLANTED.

  Patient problems: Bacterial Infection; Insufficient Information

  MAUDE report 11782673 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THERE WAS A STREPTOCOCCAL BIOFILM FORMATION. AS OF FURTHER RECEIVED INFORMATION, THE RECIPIENT HAD AN EDEMA ABOVE THE IMPLANT WITH SOME OPEN SKIN. THE IMPLANT WAS SURGICALLY EXPLORED AND THERE WAS MASSIVE GRANULATION TISSUE AROUND AND UNDER THE IMPLANT.

  Patient problems: Bacterial Infection

  MAUDE report 10883625 ↗
• InjuryOct 29, 2020Output Problem; Output Problem

  IMPEDANCES ON THE CONCERNED RIGHT SIDE HAVE CHANGED OVER TIME. NO ACCIDENT OR TRAUMA HAS BEEN REPORTED. RE-IMPLANTATION TOOK PLACE ON (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10754732 ↗
• MalfunctionAug 3, 2020Defective Device

  DURING A BILATERAL COCHLEAR IMPLANTATION, THE DOCTOR COULD NOT CONFIRM THAT THE SYNCHRONY 2 COCHLEAR IMPLANT HAD SUCCESSFULLY COILED, EVEN AFTER SEVERAL X-RAY WHERE TAKEN. IT WAS DECIDED TO USE A SMALLER COCHLEAR IMPLANT WHICH SUCCESSFULLY COILED AS CONFIRMED BY X-RAY IMAGING. THE DEFECTIVE SYNCHRONY 2 COCHLEAR IMPLANT WAS RETURNED TO THE MANUFACTURER ON JULY 23RD. THE COMPANY INFORMED UF THAT, ACCORDING TO FDA REGULATIONS, THE IMPLANT THAT WAS NOT USED DURING THE SURGICAL PROCEDURE MUST BE RETURNED TO THE COMPANY. COMPANY SENT AN OVER-NIGHT SHIPPING PACKAGE TO OBTAIN THE DEVICE. ONCE THE DEFECTIVE PRODUCT IS RETURNED, THE COMPANY WILL INVESTIGATE THE PROBLEM WITH THE DEVICE AND CONSIDER IF UF MUST BE REIMBURSED DUE TO ITS MALFUNCTIONING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10355414 ↗
• MalfunctionJun 8, 2020Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE USER WAS IMPLANTED ON (B)(6) 2020. AT ACTIVATION ON (B)(6) 2020 IT WAS NOTICED THAT THE IMPLANT LOCATION WAS LOWER THAN EXPECTED. THE USER COMPLAINED THAT THE AUDIO PROCESSOR FALLS OFF AND THE LOCATION OF THE EXTERNAL DEVICE MOVES WITH BASIC HEAD MOVEMENTS. ON (B)(6) 2020, THE RECIPIENT WAS INTUBATED AND ANESTHETIZED. THE DEVICE WAS PALPATED AND IMAGED AND IT WAS DETERMINED THAT IT HAD NOT MOVED FROM ITS INTENDED POSITION AND HAD NOT MIGRATED FROM THE POCKET AS INITIALLY THOUGHT. NO SURGERY WAS PERFORMED. AS OF INFORMATION RECEIVED ON THE 6TH AUGUST THE RETENTION WITH THE SONNET IS SLIGHTLY BETTER WITH A WEAR TIME OF AROUND 4 HOURS A DAY. THE CLINIC IS TRYING TO GET THE USER TO INCREASE THE WEAR TIME BEFORE ANY NEW PLANS ARE MADE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10127366 ↗

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-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