Mi1250 SYNCHRONY 2 COMPRESSED 36676Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 09008737366766), received between Mar 23, 2020 and Apr 3, 2026 — classified as 6 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Device Appears to Trigger Rejection; Migration

  THE ELECTRODES ARRAY MIGRATED OUT OF COCHLEA. THE USER WAS REIMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 24773795 ↗
• InjuryFeb 17, 2026Device Appears to Trigger Rejection; Adverse Event Without Identified Device or Use Problem

  THE DEVICE IS EXTRUDING THROUGH THE SKIN. A REVISION SURGERY TO REPOSITION THE IMPLANT AND DO A ROTATION FLAP IS PLANNED.

  Patient problems: Skin Tears; Tissue Breakdown

  MAUDE report 24362109 ↗
• InjuryFeb 14, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE USER HAS BEEN EXPLANTED DUE TO AN EXTRUSION OF THE ELECTRODE IN THE EXTERNAL AUDITORY CANAL.

  Patient problems: Skin Tears

  MAUDE report 21383293 ↗
• MalfunctionOct 8, 2024Impedance Problem; Impedance Problem

  DURING A FOLLOW UP SESSION, ABNORMAL IN SITU MEASUREMENTS WERE OBSERVED. THE USES HAS BEEN RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2025.

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

  MAUDE report 20394865 ↗
• MalfunctionDec 21, 2023Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. CT IMAGING HAS BEEN SCHEDULED. THE USER WILL BE MONITORED.

  Patient problems: Failure of Implant

  MAUDE report 18375809 ↗
• MalfunctionNov 2, 2023Migration; Migration

  THE USER HEARS A BUZZING NOISE WHEN SPEAKING. ON JUNE 01, 2022, IT WAS DETERMINED THAT THE ELECTRODE MIGRATED, AND SOME CONTACTS WERE OUTSIDE OF THE COCHLEA. RE-INSERTION SURGERY TOOK PLACE ON JULY 22, 2022. SHORTLY AFTER THAT, THE ELECTRODE MIGRATED AGAIN, AND A SECOND RE-INSERTION SURGERY WAS DONE ON JULY 26, 2022. THEN THE ELECTRODE MIGRATED AGAIN ON (B)(6) 2023. NO FURTHER SURGICAL INTERVENTION WAS DONE. A DIAGNOSTIC IMAGE TO SEE THE CURRENT ELECTRODE POSITION WILL BE PERFORMED.

  Patient problems: Failure of Implant

  MAUDE report 18053355 ↗
• InjurySep 13, 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 USER HAS BEEN EXPLANTED WITHOUT A NEW IMPLANTATION. FIBROSIS OVER THE IMPLANT WAS REPORTED; THE USER HAD PAIN ON THE IMPLANT SIDE. IT IS UNKNOWN WHEN THE ISSUE STARTED.

  Patient problems: Fibrosis; Pain

  MAUDE report 17734896 ↗
• MalfunctionJan 4, 2023Migration; Migration

  INFORMATION WAS INITIALLY RECEIVED IN JUNE 2022 THAT THE RECIPIENT HAS NO HEARING RESPONSES WITH THE CURRENT DEVICE. AS OF INFORMATION RECEIVED ON THE 4TH OF JULY 2022 THE USER SEEMS TO BE RESPONDING SLIGHTLY WITH THEIR DEVICES. HOWEVER, AS OF LATER INFORMATION THE MOTHER REPORTS NOT SEEING ANY RESPONSE TO SOUND AT HOME DESPITE DATA LOGGING SHOWING 8.9 HOURS AS AVERAGE USE OF THE DEVICE. NEW INFORMATION RECEIVED IN DECEMBER 2022 STATED THAT THE ARRAY IS COMPLETELY EXTRA-COCHLEAR. ACCORDING TO THE IMPLANT REGISTRATION CARD, 5 CHANNELS WERE LEFT EXTRA-COCHLEAR AT IMPLANTATION. THE RECIPIENT WILL BE FOLLOWED UP IN (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 16093243 ↗
• MalfunctionNov 14, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THIS USER HAS STARTED EXPERIENCING CONTINUED ISSUES WITH THE LEFT DEVICE. PROGRAMMING CHANGES WERE MADE IN JULY 2022 TO ADDRESS TWO AFFECTED CHANNELS AND IN OCTOBER 2022 THE RECIPIENT STARTED NOTICING PERCEPTUAL SOUND CHANGES IN THE LEFT EAR ONLY WHEN TURNING OR TILTING THE HEAD, AND WHEN PUSHING ON HIS LEFT TRAGUS. ON (B)(6) 2022 AN INTEGRITY TEST WAS COMPLETED DUE TO CONCERNS OF FLUCTUATIONS WITH IMPEDANCES AND PERCEPTUAL SOUND CHANGES. THE SOUND CHANGES ARE DESCRIBED AS MAKING SOUNDS MORE BASE LIKE AND MUFFLED. THIS SEEMS TO AFFECT LOWER FREQUENCY VOICES. THIS HAPPENS WHILE WALKING AND LOOKING AROUND, WHILE DRIVING, AND WHILE LEANING ON HIS FIST. ALSO, IT HAS ALSO BEEN NOTICED SINCE JULY 2022 THAT HIS IMPLANT HOUSING APPEARS TO BE MOVING. A REVISION SURGERY IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 15788557 ↗
• InjuryJul 13, 2022Device 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 WAS IMPLANTED IN (B)(6) 2022 AND AFTER SOME TIME THERE WAS SWELLING IN THE IMPLANT AREA THEN THE ELECTRODE EXTRUDED THROUGH THE SKIN. ONLY 5 CHANNELS WERE INSERTED INTO THE COCHLEA AND 7 CHANNELS WERE LEFT EXTRA-COCHLEAR AT IMPLANTATION DUE TO THE USER'S ANATOMY. A REVISION SURGERY WILL BE PERFORMED IN A MONTHS TIME.

  Patient problems: Skin Tears; Tissue Breakdown

  MAUDE report 14998620 ↗
• MalfunctionJul 6, 2022No Device Output; Output Problem; No Device Output; Output Problem

  THE USER WAS RECENTLY IMPLANTED WITH THE DEVICE BUT DUE TO SEVERE MALFORMATIONS IN THE COCHLEA 9 ELECTRODES WERE LEFT EXTRA-COCHLEA OF THE COMPRESSED ARRAY. AT A RECENT FOLLOW-UP SESSION AFFECTED CHANNELS WERE SEEN. THE PARENTS REPORTED A HEAD TRAUMA OVER THE IMPLANT. A CT SCAN HAS BEEN REQUESTED.

  Patient problems: Failure of Implant

  MAUDE report 14927743 ↗
• MalfunctionFeb 2, 2022Migration; Migration

  REPORTEDLY POST-OP IMAGING SHOWS THAT THE ACTIVE ARRAY IS EXTRA-COCHLEAR. AT INITIAL ACTIVATION, RESPONSES WERE NOT SEEN ON THE CONCERNED LEFT SIDE. A CT SCAN WILL BE PERFORMED ON THE (B)(6) .

  Patient problems: Dizziness; Failure of Implant

  MAUDE report 13420773 ↗
• InjuryMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AROUND ONE MONTH AFTER IMPLANTATION SURGERY THE RECIPIENT DEVELOPED FEVER AND WAS FEELING SICK, WAS TESTED FOR THE FLU BUT THEN RECOVERED. ON THE (B)(6) 2020 THE SAME SYMPTOMS OCCURRED, SICKNESS AND HIGH FEVER. THE USER WAS ADMITTED TO HOSPITAL AND DIAGNOSED WITH MENINGITIS, THEN RECOVERED AND WAS RELEASED ON (B)(6). THE DEVICE HAS NOT BEEN WORN SINCE BEING ADMITTED TO HOSPITAL. DUE TO THE RE-OCCURRENCE OF MENINGITIS, THE USER WAS EXPLANTED ON THE (B)(6) 2020. THIS REPORT REFERS TO 9710014-2020-00192. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Meningitis

  MAUDE report 9887442 ↗
• InjuryMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AROUND ONE MONTH AFTER IMPLANTATION SURGERY THE RECIPIENT DEVELOPED FEVER AND WAS FEELING SICK. THEY WERE TESTED FOR THE FLU BUT THEN RECOVERED. ON THE (B)(6) 2020 THE SAME SYMPTOMS OCCURRED, SICKNESS AND HIGH FEVER. THE USER WAS ADMITTED TO HOSPITAL AND DIAGNOSED WITH MENINGITIS, THEN RECOVERED AND WAS RELEASED ON THE 15TH MARCH. THE DEVICE HAS NOT BEEN WORN SINCE BEING ADMITTED TO HOSPITAL. DUE TO THE RE-OCCURRENCE OF MENINGITIS, THE USER WAS EXPLANTED ON THE (B)(6) 2020. THERE ARE NO PLANS FOR RE-IMPLANTATION.

  Patient problems: Meningitis

  MAUDE report 9864315 ↗

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