Mi1000 MED-EL CONCERT +COMPRESSED 06270Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 09008737062705), received between Jul 20, 2018 and Feb 24, 2026 — classified as 12 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Output Problem” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 24, 2026Impedance Problem

  THE USER'S IMPLANT STOPPED WORKING AFTER SUSTAINED HEAD TRAUMA IN (B)(6) 2026. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Head Injury

  MAUDE report 24430341 ↗
• MalfunctionFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE DOCTOR, THE USER EXPERIENCED MULTIPLE INFECTIONS IN THE MIDDLE EAR, AND THERE WERE CONCERNS REGARDING THE POTENTIAL FOR MENINGITIS. NO MENINGITIS OCCURRED AND THE INFECTION HAS NOT SPREAD TO THE IMPLANT SITE. THE DOCTOR ALSO MENTIONED THAT THE USER WAS NOT UTILIZING THE DEVICE AND DID THEREFORE NOT HAVE ANY BENEFIT FROM THE DEVICE. THE USER HAS BEEN EXPLANTED.

  Patient problems: Infectious Otitis Media

  MAUDE report 24255946 ↗
• MalfunctionFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE DOCTOR, THE USER EXPERIENCED MULTIPLE INFECTIONS IN THE MIDDLE EAR, AND THERE WERE CONCERNS REGARDING THE POTENTIAL FOR MENINGITIS. NO MENINGITIS OCCURRED AND THE INFECTION DID NOT SPREAD TO THE IMPLANT SITE. THE DEVICE HAS BEEN EXPLANTED.

  Patient problems: Infectious Otitis Media

  MAUDE report 24255945 ↗
• MalfunctionNov 7, 2025Impedance Problem; Impedance Problem

  THE USER EXPERIENCED A SUDDEN DECLINE IN HEARING WITH THE RIGHT IMPLANT ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23496160 ↗
• InjuryFeb 18, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE RECIPIENT PUT A COTTON BALL IN HIS EXTERNAL AUDITORY CANAL (EAC) AND WHEN HE REMOVED IT, THE IMPLANT WAS PULLED OUT FROM THE COCHLEA, IT WAS PLACED IN THE EAC. THE ELECTRODE LEAD EXTRUDED THROUGH HE TYMPANIC MEMBRANE. THE RECIPIENT HAS BEEN RE-IMPLANTED.

  Patient problems: Skin Tears

  MAUDE report 21397514 ↗
• MalfunctionNov 20, 2023Malposition of Device; Malposition of Device

  THE USER WAS IMPLANTED IN (B)(6) 2012, AND IT WAS NOT ABLE TO FULLY INSERT THE ELECTRODE. WITH THIS DEVICE THE USER NEVER REALLY GOT INTO SPEECH PERCEPTION. A REIMPLANTATION SURGERY HAS BEEN PLANNED IN (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 18168473 ↗
• MalfunctionOct 20, 2023Migration; Migration

  THE USER REPORTS A RECENT WORSENING SOUND QUALITY. THE CHANGES IN HEARING STARTED GRADUALLY IN EARLY 2022. REVISION SURGERY IS CONSIDERED, AS THE DOCTOR IN CHARGE HAD INDICATED THAT THE IMPLANT IS OUT OF PLACE. THERE IS STILL NO DATE FOR THE NEW PROCEDURE.

  Patient problems: Failure of Implant

  MAUDE report 17971948 ↗
• MalfunctionJul 17, 2023Migration; Migration

  THE USER WAS EXPLANTED ON (B)(6) 2023. AS PER EXPLANT REPORT FORM INFORMATION, THE ELECTRODE ARRAY WAS FOUND ONLY PARTIALLY INSERTED.

  Patient problems: Failure of Implant

  MAUDE report 17331473 ↗
• MalfunctionFeb 21, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER HAS BEEN ACCIDENTALLY HIT ON THE HEAD BY A TOY ON (B)(6) 2021, AND HE WAS SUBSEQUENTLY UNABLE TO HEAR.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 13568743 ↗
• MalfunctionJan 27, 2022Output Problem; Output Problem

  THE USER STOPPED HEARING AT THE END OF (B)(6) 2021. THE USER HAS BEEN RE-IMPLANTED ON (B)(6) 2022.

  Patient problems: Failure of Implant

  MAUDE report 13365943 ↗
• MalfunctionDec 6, 2021Output Problem; Output Problem

  THE USER FELL WHILE PLAYING AND HIT HIS HEAD. SUBSEQUENTLY, HE COULD NO LONGER HEAR WITH THE DEVICE AND ABNORMAL MEASUREMENTS WERE OBSERVED. THE USER HAS BEEN RE-IMPLANTED ON (B)(6), 2021.

  Patient problems: Failure of Implant

  MAUDE report 12933384 ↗
• MalfunctionJun 22, 2021Output Problem; Output Problem

  THE RECIPIENT COULD NOT HEAR ANYMORE USING THE DEVICE, THE HEARING PERCEPTION CHANGED OVERTIME. THE USER HAS BEEN REIMPLANTED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 12040404 ↗
• InjuryFeb 3, 2021Output Problem; Output Problem

  THE HEARING PERFORMANCE STARTED TO BE AFFECTED AND BECAME SIGNIFICANTLY WORSE THAN BEFORE. THE USER WERE RE-IMPLANTED WITH A NEW DEVICE ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11271568 ↗
• InjurySep 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IN 2015, USER UNDERWENT A CONTRALATERAL SIDE IMPLANTATION OF A COCHLEAR DEVICE. SINCE THIS TIME THE USER HAS HAD NO ACCESS TO SOUND FROM THE MED-EL DEVICE. PREVIOUS HEARING LEVEL UNKNOWN AS THE PATIENT IS DIFFICULT TO TEST. REPORTEDLY, IN SITU MEASUREMENTS FROM 2015 WERE WITHIN NORMAL LIMITS AND EXTERNAL EQUIPMENT HAS BEEN REPLACED. THE APPOINTMENT ON (B)(6) 2015 REVEALED NO FURTHER PROGRESS OF THE CHILD'S SPEECH OR SIGNS. INFORMATION RECEIVED ON (B)(6) 2015 STATES THAT THE CLINIC CONTINUED TO MONITOR THE PATIENT. THE LAST INTEGRITY TEST WAS PERFORMED ON (B)(6) 2019 DUE TO POOR PERFORMANCES WITH THE DEVICE. THE USER HAS BEEN EXPLANTED AND REIMPLANTED WITH A DEVICE FROM ANOTHER MANUFACTURER. THIS REPORT REFERS TO 9710014-2015-00416. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 10565782 ↗
• InjuryAug 10, 2020Output Problem; Output Problem

  THE USER'S PARENTS REPORTED AN OBVIOUS DECLINE IN HEARING PERFORMANCE WITH THE DEVICE AFTER A HEAD TRAUMA. AFTER THREE WEEKS OF OBSERVATION, HIS HEARING DIDN'T IMPROVE. THE USER HAS BEEN RE-IMPLANTED ON (B)(6) 2020.

  Patient problems: Failure of Implant; Head Injury

  MAUDE report 10385008 ↗
• InjuryAug 5, 2020Output Problem; Output Problem

  ON (B)(6) 2016 THE USER REPORTED HEARING NOISE WHEN TURNING HIS HEAD AND PRESSING ON THE IMPLANT, WHICH HAD BEEN HAPPENING FOR SOME MONTHS. THE ISSUE WAS RESOLVED BY FITTING. AS PER FURTHER RECEIVED INFORMATION, THE RECIPIENT HAS NO LONGER BEEN ABLE TO HEAR WITH THE DEVICE SINCE (B)(6) 2020.

  Patient problems: Failure of Implant

  MAUDE report 10367238 ↗
• MalfunctionFeb 10, 2020Output Problem; Output Problem

  THE USER ATTENDED A FITTING APPOINTMENT AND AFFECTED CHANNELS WERE OBSERVED. THE MOTHER SAID THAT SHE NOTICED THAT THE CHILD WAS LISTENING LESS OR NOT LISTENING FROM THE RIGHT SIDE AND REPORTED THAT THIS OCCURRED SUDDENLY.

  Patient problems: Failure of Implant

  MAUDE report 9686851 ↗
• InjuryDec 9, 2019Output Problem; Output Problem

  AT ACTIVATION IN (B)(6) 2019, IN SITU TESTING SHOWED AFFECTED CHANNELS. THE RECIPIENT HAD NO ACCESS TO SOUND WITH THE DEVICE. AFTER 3 MONTHS OF OBSERVATION, THERE WAS NO CHANGE. THERE WAS NO REPORT OF AN ACCIDENT OR TRAUMA. THE RECIPIENT WAS RE-IMPLANTED ON (B)(6) 2019, ALSO WITH +COMPRESSED ARRAY.

  Patient problems: Failure of Implant

  MAUDE report 9437355 ↗
• InjuryOct 29, 2019Output Problem; Output Problem

  THE RECIPIENT SUDDENLY HAD NO HEARING PERCEPTION WITH THE LEFT DEVICE. THERE WAS NO REPORTED EVENT THAT CAUSED THE LOSS OF BENEFIT, INCLUDING ANY TRAUMA.

  Patient problems: Failure of Implant

  MAUDE report 9250539 ↗
• InjuryJul 22, 2019Output Problem; Output Problem

  THE RECIPIENT'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED; THE RECIPIENT WAS NO LONGER RESPONDING TO SPEECH AND SOUNDS AS BEFORE. NO TRAUMA WAS REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 8811139 ↗
• InjuryMay 23, 2019Output Problem; Output Problem

  RECIPIENT IS REPORTED TO HAVE FALLEN AND HIT HIS HEAD AFTER WHICH HE LOST ACCESS TO SOUND WITH THE DEVICE. THERE WAS NO REDNESS OR SWELLING OVER THE IMPLANT SITE. REIMPLANTATION IS SCHEDULED FOR (B)(6) 2019.

  Patient problems: Failure of Implant

  MAUDE report 8634916 ↗
• InjuryNov 28, 2018Output Problem; Output Problem

  THE USER IS REPORTED TO HAVE LOST ACCESS TO SOUND WITH THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 8109817 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER IS REPORTED TO HAVE HAD MENINGITIS SEVERAL TIMES. THE DEVICE WAS EXPLANTED TO ALLOW FOR HIGH RESOLUTION MRI. NO PRODUCT DEFICIENCY IS ALLEGED.

  Patient problems: Meningitis

  MAUDE report 8041063 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  IT WAS REPORTED THE RECIPIENT HAD A CSF (CEREBROSPINAL FLUID) GUSHER DURING IMPLANTATION SURGERY. A FEW DAYS AFTER THE SURGERY THE PATIENT HAD VOMITING AND HIGH FEVER AND WAS TREATED WITH IV ANTIBIOTICS; THE FEVER REDUCED. LATER CSF DROPS WERE COMING FROM THE NOSE AND SO IT WAS DECIDED TO TAKE THE RECIPIENT INTO SURGERY TO REPAIR THE CSF LEAK. THE REPAIR SURGERY TOOK PLACE ON (B)(6) 2018. IT WAS SUBSEQUENTLY REPORTED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO ANOTHER EPISODE OF CSF LEAKAGE. ON (B)(6) 2018 THE RECIPIENT WAS TAKEN INTO SURGERY. THE DEVICE WAS REMOVED, THE SOURCE OF THE CSF LEAKAGE SEALED AND THE DEVICE REINSERTED UNDER GENERAL ANESTHESIA.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7705728 ↗

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. Mi100
• 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-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