Mi1250 SYNCHRONY 2 FLEX28 36682Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 09008737366827), received between Jan 16, 2020 and Sep 15, 2026 — classified as 45 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Migration” (33 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 25 most recent of 108 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Impedance Problem

  In situ measurements show 4 channels with high impedance.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772732 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Because of persistent swelling and suspected infection, the cochlear implant was explanted. Meanwhile, a new cochlear implant was implanted in the contralateral ear to maintain the user's auditory rehabilitation.

  Patient problems: Medical device site infection; Unspecified Infection

  MAUDE report 50050721 ↗
• InjuryMay 28, 2026Device Appears to Trigger Rejection

  REPORTEDLY, THE ELECTRODE LEAD HAS PIERCED THE WALL OF THE EAR CANAL. THE DEVICE WAS EXPLANTED ON (b)(6)2025.

  Patient problems: Skin Tears

  MAUDE report 25315046 ↗
• MalfunctionMay 19, 2026Impedance Problem

  THE HEARING PERFORMANCE IS AFFECTED AND IN SITU TESTING SHOWED AFFECTED CHANNELS. THE USER IS SCHEDULED FOR REIMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25214011 ↗
• MalfunctionMay 18, 2026Circuit Failure

  THE USER HAS NO HEARING SENSATION WITH THE DEVICE. REIMPLANTATION IS CONSIDERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25199775 ↗
• MalfunctionMar 24, 2026Migration

  THE IMPLANT HOUSING HAD SHIFTED AND THE PATIENT'S UNDERSTANDING HAD DETERIORATED. THE IMPLANT WAS DAMAGED DURING THE REPOSITION SURGERY, THEREFORE THE USER WAS REIMPLANTED WITH A NEW DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679049 ↗
• InjuryMar 23, 2026Device Appears to Trigger Rejection; Insufficient Device Problem Information

  THE USER HAD AN EXTRUSION OF THE ELECTRODE ARRAY DUE TO AN INFECTION AND THE CUL-DE-SAC CLOSURE OF THE EAR CANAL. THE SURGEON EXPLANTED THE DEVICE AND IMPLANTED A NEW ONE.

  Patient problems: Tissue Breakdown

  MAUDE report 24661627 ↗
• MalfunctionFeb 5, 2026Impedance Problem

  THE HEARING PERFORMANCE IS AFFECTED. THE USER WAS REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268114 ↗
• MalfunctionJan 21, 2026Impedance Problem

  THE DEVICE WAS EXPLANTED DUE TO POOR SOUND QUALITY. THE USER HAS BENE REIMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129937 ↗
• MalfunctionDec 19, 2025Impedance Problem; Impedance Problem

  THE USER'S SPEECH-TEST SCORES DECLINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848473 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER WAS INITIALLY SCHEDULED TO UNDERGO A REVISION SURGERY DUE TO INFLAMMATION AROUND THE IMPLANT. THE USER WAS REIMPLANTED.

  Patient problems: Inflammation

  MAUDE report 23646636 ↗
• MalfunctionNov 18, 2025Impedance Problem; Impedance Problem

  THE USER WAS RE-IMPLANTED DUE TO PERFORMANCE DETERIORATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23579831 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT HAS EXPLANTATION/RE-IMPLANT SURGERY BOOKED FOR (B)(6) 2025 DUE TO ONGOING INFECTIONS.

  Patient problems: Unspecified Infection

  MAUDE report 23531394 ↗
• MalfunctionOct 17, 2025Impedance Problem; Impedance Problem

  THE SURGEON HAD DIFFICULTY WITH THE INSERTION ITSELF AND SPENT A LONG TIME HANDLING THE ELECTRODE. DUE TO CONCERNS OVER THE POOR ART RESPONSE, THE SURGEON PREFERRED TO USE THE BACK-UP DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23321755 ↗
• InjuryOct 8, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  A CHOLESTEATOMA DEVELOPED WHICH RESULTED IN A DEHISCENCE WHICH LIKELY WEAKENED THE BLIND-SAC AND ALLOWED THE ELECTRODE TO EXTRUDE. THE USER WAS RE-IMPLANTED.

  Patient problems: Skin Tears

  MAUDE report 23242060 ↗
• MalfunctionAug 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AN EXPLANT SURGERY OCCURRED ON (B)(6) 2025, DUE TO POOR PERFORMANCE WITH THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22783708 ↗
• InjuryJul 17, 2025Migration; Migration

  THE RECIPIENT RETURNED TO CENTER WITH CONCERNS FOR CHANGES IN IMPEDANCE. THE USER HAS BEEN RE-IMPLANTED. THE ELECTRODE LEAD WAS FOUND TO HAVE EXTRUDED THROUGH THE TYMPANIC MEMBRANE AND 2 + CHANNELS WERE FOUND EXTRA-COCHLEAR. THIS REPORT REFERS TO 9710014-2025-00015. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Head Injury

  MAUDE report 22528422 ↗
• InjuryMay 16, 2025Impedance Problem; Impedance Problem

  THE RECIPIENT RETURNED TO CENTER WITH CONCERNS FOR CHANGES IN IMPEDANCE ON CHANNELS 10-12 THAT OCCURRED IN FEBRUARY 2025 MEASURED VIA SCHOOL AUDIOLOGIST. RE-IMPLANTATION IS PLANNED FOR (B)(6) 2025.

  Patient problems: Head Injury

  MAUDE report 22033768 ↗
• MalfunctionMar 18, 2025Impedance Problem; Impedance Problem

  REPORTEDLY, THE USER HAS ALMOST NO SOUND RESPONSE. THE USER WAS RE-IMPLANTED ON (B)(6) 2025.

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

  MAUDE report 21633294 ↗
• MalfunctionMar 11, 2025Circuit Failure; Circuit Failure

  THE USER SUFFERED FROM A TEMPORAL BONE FRACTURE AND HAS SINCE THEN HAD NO HEARING PERCEPTION. RE-IMPLANTATION IS BEING CONSIDERED AND WAS SCHEDULED FOR (B)(6) 2025, HOWEVER DUE TO A HEART CONDITION HAD TO BE POSTPONED. NO NEW DATE HAS BEEN SET YET.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 21573312 ↗
• InjuryFeb 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER'S MOTHER REPORTED THAT HER CHILD'S IMPLANT WAS COMING OUT OF HER HEAD. AT IMPLANTATION 2 CHANNELS WERE LEFT EXTRA-COCHLEAR. THE USER HAS BEEN EXPLANTED ON (B)(6) 2025. IT HAS BEEN DECIDED TO WAIT FOR THE SKIN TO HEAL BEFORE PROCEEDING WITH REIMPLANTATION. THIS REPORT REFERS TO 9710014-2025-00158. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Skin Tears

  MAUDE report 21399236 ↗
• InjuryFeb 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER'S MOTHER REPORTED THAT HER CHILD'S IMPLANT WAS COMING OUT OF HER HEAD. THE CHILD HAD BEEN HOLDING HER HEAD FOR THE PAST FEW DAYS, BUT THE MOTHER DID NOT NOTICE THE IMPLANT PROTRUDING UNTIL THE NIGHT OF (B)(6) 2025. THE USER HAS BEEN EXPLANTED ON (B)(6) 2025. IT HAS BEEN DECIDED TO WAIT FOR THE SKIN TO HEAL BEFORE PROCEEDING WITH REIMPLANTATION.

  Patient problems: Skin Tears

  MAUDE report 21396030 ↗
• MalfunctionFeb 12, 2025Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. THE USER HAS REPORTEDLY NOT USED HIS AUDIO PROCESSOR FOR THE LAST YEAR STATING HE ONLY HEARS NOISE WITH IT. THE USER HAS BEEN REIMPLANTED.

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

  MAUDE report 21364626 ↗
• MalfunctionFeb 12, 2025Impedance Problem; Impedance Problem

  THE HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE USER WAS REIMPLANTED.

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

  MAUDE report 21364318 ↗
• MalfunctionFeb 4, 2025Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. TWO MONTHS AFTER SURGERY, 4 CHANNELS SHOWED HIGH IMPEDANCE, BUT THE USER WAS STILL HAPPY WITH THE SOUND QUALITY WHEN ALL CHANNELS WERE ACTIVE AND REFUSED ADJUSTMENTS. HOWEVER, IN (B)(6) 2025, THE USER COMPLAINED TO HER FAMILY THAT THE SOUND SUDDENLY BECAME VERY SOFT AND WIRED WITH HEAD MOVEMENT (SOUND WAS PRESENT WHEN HER HEAD WAS STRAIGHT BUT DISAPPEARED WHEN TILTED) FOR 2 DAYS THEN THE SOUND DISAPPEARED. SPEECH UNDERSTANDING HAS DETERIORATED. RE-IMPLANTATION IS CONSIDERED.

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

  MAUDE report 21305021 ↗

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 Product
• 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