Mi1260 SONATA 2 FLEX24 38543Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 09008737385439), received between Mar 13, 2024 and Nov 25, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  ON (B)(6) 2025, A SURGICAL INTERVENTION WAS PERFORMED DUE TO DEHISCENCE OF THE SURGICAL SCAR, WHICH RESULTED IN AN IMPLANT EXPOSURE. THE USER HAS BEEN EXPLANTED.

  Patient problems: Wound Dehiscence

  MAUDE report 23643544 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE RECIPIENT SUFFERED A HIT AND A HEAD INJURY THAT EXPOSED THE IMPLANT HOUSING. A REPOSITIONING SURGERY HAS BEEN PERFORMED ON (B)(6) 2024. THE RECIPIENT WAS SEEN FOR A FOLLOW-UP. IMAGING HAS BEEN PERFORMED SHOWING SEVERAL CHANNELS BEING EXTRA-COCHLEAR. REPORTEDLY, NO IMAGING HAS BEEN DONE PRIOR TO THE INTERVENTION ON (B)(6) 2024. ANOTHER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 TO RE-INSERT THE ELECTRODE. THE IMPLANT WAS REMOVED, THE AREA WAS CLEANED AND THE IMPLANT WAS REINSERTED BY MEANS OF A POSTERIOR TYMPANOTOMY (PREVIOUSLY IT HAD BEEN DONE THROUGH AN ENDOMEATAL APPROACH). THE RECIPIENT WAS SEEN FOR A FOLLOW-UP ON (B)(6) 2025 WHERE HE SHOWED GOOD PERFORMANCE WITH THE DEVICE. HOWEVER, IN (B)(6) 2025 THE DEVICE EXTRUDED AGAIN AND REVISION SURGERY IS SCHEDULED FOR (B)(6) 2025.

  Patient problems: Head Injury

  MAUDE report 21992599 ↗
• MalfunctionApr 22, 2025Migration; Migration

  ABOUT 6 MONTHS AGO THE RECIPIENT STARTED EXPERIENCING A LACK OF HEARING WITH THE DEVICE. THE RECIPIENT'S FAMILY REPORTED THAT THE RECIPIENT HAD A TRAUMA IN THE IMPLANT REGION. THE RECIPIENT HAS BEEN RE-IMPLANTED WITH A NEW DEVICE.

  Patient problems: Head Injury

  MAUDE report 21879373 ↗
• MalfunctionDec 17, 2024Migration; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE DEVICE WAS EXPLANTED AS THE ACTIVE ELECTRODE WAS FOUND COMPLETELY OUT OF THE COCHLEA. THE RECIPIENT HAS BEEN RE-IMPLANTED, BUT THE NEW DEVICE COULD NOT BE CORRECTLY INSERTED INTO THE COCHLEA DUE TO FIBROSIS AND OSSIFICATION.

  Patient problems: Failure of Implant

  MAUDE report 20949310 ↗
• MalfunctionNov 11, 2024Impedance Problem; Impedance Problem

  THE RECIPIENT_S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. THE RECIPIENT HAS BEEN RE-IMPLANTED.

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

  MAUDE report 20649734 ↗
• MalfunctionJun 13, 2024Device Appears to Trigger Rejection; Migration; Device Appears to Trigger Rejection; Migration

  IT WAS REPORTED THAT THE DEVICE MIGRATED FROM ITS INTENDED POSITION TO THE POSTERIOR PART OF THE PINNA STARTING ONE MONTH AFTER THE USE OF THE EXTERNAL DEVICE. THE SURGICAL WOUND AFTER INITIAL IMPLANTATION HEALED PROPERLY. DURING PREPARATIONS FOR THE REVISION SURGERY, AN EXTRUSION OF BOTH THE IMPLANT STIMULATOR AND THE ELECTRODE LEAD WAS DETECTED. DURING THE SURGERY POST INFECTION SIGNS HAVE BEEN OBSERVED IN THE TISSUE SURROUNDING THE IMPLANT. REPORTEDLY THE EXTRUSION WAS CAUSED BY THE PRESSURE APPLIED BY THE STIMULATOR HOUSING ON THE SKIN. INFECTION IS THOUGHT TO HAS OCCURRED DUE TO THE EXTRUSION. DURING THE OPENING OF THE WOUND THE ELECTRODE LEAD EXIT WAS ACCIDENTALLY CUT AND A BACK-UP DEVICE WAS IMPLANTED.

  Patient problems: Skin Tears

  MAUDE report 19526437 ↗
• InjuryApr 9, 2024Device 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

  ON (B)(6) 2024, THE USER WAS SCHEDULED FOR A REVISION SURGERY. DURING THE SURGERY IT WAS DISCOVERED THAT THE ACTIVE ELECTRODE ARRAY HAD COMPLETELY COME OUT OF THE COCHLEA AND WAS VISIBLE OUTSIDE THE SKIN AND PINNA. THE USER SUFFERED FROM A SKIN PROBLEM, WHICH CAUSED THE WOUND AND TISSUE TO OPEN, AND IT APPEARED THAT THE USER HAD PULLED OUT THE ELECTRODE CABLE. CONSEQUENTLY, THE ACTIVE ELECTRODE ARRAY BECAME DISLODGED FROM THE COCHLEOSTOMY, RESULTING IN HEARING LOSS. THE MEDICAL TEAM SUSPECTS THAT AN ACTIVE INFECTION MAY HAVE CONTRIBUTED TO THE WOUND OPENING. ADDITIONALLY, THERE WERE SIGNS OF AN INFECTION OBSERVED DURING THE SURGERY, WITH THE IMPLANT BEING COVERED BY FIBROTIC TISSUE WITHIN A TISSUE BAG. A NEW DEVICE WAS IMPLANTED AS A PRECAUTION AGAINST INFECTION AND DUE TO EXTRUSION OF THE ELECTRODE ARRAY. THE ACTIVATION OF THE NEW DEVICE IS SCHEDULED TO TAKE PLACE IN ONE MONTH AFTER THE MEDICAL ASSESSMENT.

  Patient problems: Tissue Breakdown; Unspecified Infection

  MAUDE report 19069356 ↗
• MalfunctionMar 13, 2024Impedance Problem; Migration; Impedance Problem; Migration

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED. REPORTEDLY, THE USER HAD ONLY 3 FUNCTIONING CHANNELS, AS CHANNELS HAVE BEEN GRADUALLY DEACTIVATED OVER TIME, STARTING IN DECEMBER 2023. THE USER HAS BEEN EXPLANTED AND RE-IMPLANTED WITH A NEW DEVICE FROM ANOTHER MANUFACTURER.

  Patient problems: Failure of Implant

  MAUDE report 18892555 ↗

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-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
• 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