Mi1250 SYNCHRONY 2 FLEX24 36680Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 09008737366803), received between Jun 4, 2020 and Jun 12, 2026 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Migration” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 12, 2026Impedance Problem

  REPORTEDLY, THERE IS BLISTERING AND DRAINAGE OVER THE MAGNET SITE. USER WILL BE EXPLANTED.

  Patient problems: Skin Infection

  MAUDE report 25483151 ↗
• InjuryJun 10, 2026Impedance Problem

  REPORTEDLY, THERE IS BLISTERING AND DRAINAGE OVER THE MAGNET SITE. USER WILL BE EXPLANTED.

  Patient problems: Skin Infection

  MAUDE report 25457233 ↗
• MalfunctionMay 21, 2026Impedance Problem

  HEARING PERFORMANCE WITH THE DEVICE IS BELIEVED TO BE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25240851 ↗
• MalfunctionMar 7, 2025Migration; Migration

  AFTER A SKIING ACCIDENT, THE DEVICE MOVED OUT OF THE COCHLEAR, AS CONFIRMED BY CT IMAGES. A CHANGE IN HEARING WAS NOT REPORTED. RE-POSITIONING SURGERY IS CONSIDERED, BUT THE USER CURRENTLY IS SUFFERING FROM AN INFECTION.

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

  MAUDE report 21544535 ↗
• MalfunctionDec 18, 2024Impedance Problem; Impedance Problem

  DURING THE INITIAL SURGERY ON (B)(6) 2024, THE SURGEON WAS UNABLE TO FULLY INSERT THE ELECTRODE INTO THE COCHLEA. THE USER WAS RE-IMPLANTED WITH A NEW DEVICE ON THE SAME DAY. HOWEVER, INTRA-OPERATIVE IN-SITU MEASUREMENTS REVEALED HIGH CHANNELS FOR THIS NEW DEVICE, SO IT WAS DECIDED TO REPLACE THE RE-IMPLANT AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20966304 ↗
• MalfunctionJan 30, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE IS AFFECTED. THERE ARE CONCERNS THAT THE INTERNAL DEVICE MIGHT HAVE SHIFTED. THE CHILD WAS RESPONSIVE AND WOULD OFTEN GIGGLE AND TURN TO SOUNDS. HE DOES NOT HAVE VERBAL SPEECH PRODUCTION, BUT THEY SUSPECT HE HAD SPEECH UNDERSTANDING. IMAGING IS NOT YET SCHEDULED.

  Patient problems: Failure of Implant

  MAUDE report 18605510 ↗
• MalfunctionMay 11, 2023Circuit Failure; Circuit Failure

  THE LINK CHECK IN THE DL COIL ALSO SHOWS A RED FLASHING WHEN OVER THE IMPLANT. THE MOTHER REPORTS THAT THE CHILD REACTED. IN THE LAST WEEK IT FELL ON THE PLAYGROUND ON ITS HEAD ON THE IMPLANTED SIDE ,NO SWELLING VISIBLE OVER THE IMPLANT. REIMPLANTATION IS SCHEDULED AS SOON AS POSSIBLE.

  Patient problems: Failure of Implant

  MAUDE report 16910615 ↗
• MalfunctionApr 12, 2023Impedance Problem; Impedance Problem

  IN SITU TESTING SHOWED AFFECTED CHANNELS. IT WAS REPORTED THAT THE USER IS HIGHLY ACTIVE, WHICH LEADS TO CONTINUOUS FALLS ON THE FLOOR. MOREOVER, THE USER HAS HIT HIS HEAD DAILY WITH HIS OWN HANDS.

  Patient problems: Failure of Implant

  MAUDE report 16723430 ↗
• MalfunctionApr 12, 2023Migration; Migration

  DURING ACTIVATION, THE USER EXPERIENCED NON-AUDITORY SENSATIONS. IMAGING CONFIRMED THE PRESENCE OF EXTRA-COCHLEAR CHANNELS. A REVISION SURGERY TOOK PLACE, AND THE ELECTRODE ARRAY WAS FULLY RE-INSERTED AGAIN ON (B)(6) 2023. DURING INITIAL IMPLANTATION ON (B)(6) 2023 AND A FULL INSERTION OF THE ARRAY WAS ACHIEVED. THE USER WAS ACTIVATED AND IS NOW USING HER AUDIO PROCESSOR. ELECTRODES 11 AND 12 HAD TO BE DISABLED BECAUSE OF NO AUDITORY PERCEPTION. APART FROM THAT, EVERYTHING IS FINE.

  Patient problems: Failure of Implant

  MAUDE report 16723425 ↗
• MalfunctionDec 15, 2021Output Problem; Output Problem

  THE USER WAS IMPLANTED ON THE (B)(6) 2021 AND ACTIVATED ON THE (B)(6). HOWEVER, AT THE ACTIVATION MAXIMUM MCL LEVELS WERE REACHED WITHOUT INDUCING ANY AUDITORY STIMULATION. TROUBLE SHOOTING ATTEMPTS WERE MADE BUT STILL NO AUDITORY SENSATION COULD BE ACHIEVED. IMAGING FROM THE (B)(6) 2021 WOULD SHOW ALL CHANNELS OUTSIDE THE COCHLEA. THE USER WILL BE RE-IMPLANTED IN (B)(6).

  Patient problems: Failure of Implant

  MAUDE report 13008287 ↗
• MalfunctionOct 29, 2021Migration; Migration

  REPORTEDLY 3 CHANNELS WERE EXTRA-COCHLEAR. A REVISION SURGERY OCCURRED ON THE (B)(6) 2021 AND THE ARRAY WAS RE-INSERTED. HOWEVER, AFTER THE SURGERY THE ARRAY BACKED OUT AGAIN. THE RECIPIENT WILL BE REVISED WHEN THE FIXATION CLIP ARRIVES IN THE US PENDING APPROVAL.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 12717486 ↗
• InjuryJul 8, 2021Migration; Migration

  THE USER WAS IMPLANTED WITH A FLEX24 DUE TO RESIDUAL HEARING. PERFORMANCE ONE MONTH AFTER THE FIRST FITTING WAS GOOD. UNFORTUNATELY, THE USER LOST HIS RESIDUAL HEARING (UNKNOWN REASON). ADDITIONALLY, THE USER HAD NO MORE BENEFIT FROM THE TWO MOST BASAL ELECTRODES AND THE SOUND BECAME UNPLEASANT ON THESE CHANNELS. DURING FITTING IT WAS NOT POSSIBLE TO RECEIVE AUDITORY SENSATION WITHOUT THE NON-AUDITORY SIDE-EFFECTS. THE USER WAS RE-IMPLANTED WITH A FLEX 28 ARRAY. THE USER IS PERFORMING VERY WELL WITH THE NEW DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 12133272 ↗
• InjuryMar 9, 2021Migration; Migration

  THE USER SAW THE SURGEON ON (B)(6) 2021 FOR SIGNIFICANT PAIN OVERLYING THE IMPLANT SITE BOTH WITH AND WITHOUT EXTERNAL DEVICE ON HER HEAD. THE PAIN WAS FIRST REPORTED ON 19-JAN-2021 AS THE USER WAS NOT ABLE TO WEAR THE DEVICE DUE TO PAIN FOR ONE WEEK PRIOR TO THIS. THE PAIN IS WORSE WITH USE OF THE DEVICE. THE PERFORMANCE WITH THE DEVICE HAS BEEN POOR BUT THE REASON FOR THE REVISION SURGERY IS THE PAIN AND INABILITY TO WEAR THE DEVICE. REPORTEDLY, THE HOUSING LIKELY SHIFTED LOWER IN THE POCKET POST-OPERATIVELY. RE-IMPLANTATION WAS PERFORMED ON THE (B)(6) 2021 AND THE CONCERNED DEVICE WAS FOUND WITH 3 EXTRA-COCHLEAR CHANNELS. AT EXPLANTATION THE DEVICE HOUSING WAS FOUND STABLE.

  Patient problems: Implant Pain

  MAUDE report 11441536 ↗
• InjuryMar 3, 2021Output Problem; Migration; Output Problem; Migration

  THE USER SAW THE SURGEON ON THE (B)(6) 2021 FOR SIGNIFICANT PAIN OVERLYING THE IMPLANT SITE BOTH WITH AND WITHOUT EXTERNAL DEVICE ON HER HEAD. THE PAIN WAS FIRST REPORTED ON THE (B)(6) 2021 AS THE USER WAS NOT ABLE TO WEAR THE DEVICE DUE TO PAIN FOR ONE WEEK PRIOR TO THIS. THE PAIN WAS WORSE WITH USE OF THE DEVICE AND WAS DESCRIBED AS A PHYSICAL PAIN. THE PERFORMANCE WITH THE DEVICE HAS BEEN POOR. RE-IMPLANTATION WAS PERFORMED ON THE (B)(6) 2021 AND THE CONCERNED DEVICE WAS FOUND WITH 3 EXTRA-COCHLEAR CHANNELS. MIGRATION OF THE 3 MOST BASAL CHANNELS HAD BEEN SUGGESTED BY IMAGING AS WELL. THE REPORTED REASON FOR THE REVISION SURGERY WAS PAIN AND INABILITY TO WEAR THE DEVICE; HOWEVER, THE EXPLANT REPORT FORM INDICATES AS REASON FOR EXPLANTATION THE DEVICE EXTRUSION FROM THE COCHLEA. REPORTEDLY, IT IS THEORIZED THAT THE MIGRATION OF THE ELECTRODE MAY BE CAUSING THE PAIN.

  Patient problems: Implant Pain

  MAUDE report 11403391 ↗
• InjuryNov 23, 2020Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE ELECTRODE ARRAY EXTRUDED. AT A REVISION SURGERY IT WAS TRIED TO RE-INSERT THE ELECTRODE BUT SCAR TISSUE WAS FOUND WHICH COULD NOT BE REMOVED WITHOUT DAMAGE TO THE ARRAY. THEREFORE, THE USER WAS RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 10883121 ↗
• InjuryNov 19, 2020Positioning Problem; Migration; Migration

  THE RECIPIENT'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE ELECTRODE ARRAY MIGRATED OUT OF THE COCHLEA. THE RECIPIENT HAD SOUND AWARENESS AT ACTIVATION. HOWEVER, AT HER TWO-WEEK MAPPING SHE WAS NOT RESPONDING WELL WHEN INDIVIDUAL CHANNELS WERE STIMULATED. THE PARENT REPORTED THAT THE RECIPIENT FELL AND HIT HER HEAD ON THE GROUND BETWEEN ACTIVATION AND THE 2-WEEK MAPPING APPOINTMENT. THE RECIPIENT WAS RE-IMPLANTED.

  Patient problems: Head Injury; Therapeutic Response, Decreased

  MAUDE report 10866532 ↗
• MalfunctionJun 4, 2020Device 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

  REPORTEDLY, AROUND 2 MONTHS AFTER IMPLANTATION SURGERY THE USER'S RESIDUAL HEARING DISAPPEARED. AT THIS TIME THE USER ALSO SUFFERED FROM TINNITUS AND VERTIGO. THE SOUND PERFORMANCE RECEIVED BY THE IMPLANT WAS REPORTED TO HAVE DECREASED SIGNIFICANTLY. AN ELECTRODE EXTRUSION IS SUSPECTED.

  Patient problems: Dizziness; Tinnitus

  MAUDE report 10118406 ↗

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-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
• 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