Mi1000 MED-EL CONCERT PIN +FLEX24 06273Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 09008737062736), received between Dec 5, 2018 and Nov 19, 2024 — classified as 6 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Output Problem” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Impedance Problem; Impedance Problem

  THE USER HAD A SUDDEN LOSS OF HEARING SENSATION. RE-IMPLANTATION IS BEING CONSIDERED.

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

  MAUDE report 20721245 ↗
• MalfunctionAug 21, 2024Impedance Problem; Impedance Problem

  THE USER HAS FLUCTUATING IMPEDANCES. THE PERFORMANCE WITH THE DEVICE IS AFFECTED. NEXT STEPS WILL BE DISCUSSED.

  Patient problems: Failure of Implant

  MAUDE report 20012871 ↗
• MalfunctionDec 4, 2023Migration; Migration

  BASED ON IMAGING FOUR CHANNELS ARE EXTRA COCHLEAR ON THE CONCERNED SIDE AND HAVE BEEN DISABLED. THE RECIPIENT HAS BEEN EXPLANTED.

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

  MAUDE report 18254491 ↗
• MalfunctionSep 27, 2022Circuit Failure; Output Problem; Circuit Failure; Output Problem

  THE USER DOES NOT HAVE HEARING SENSATION. A RE-IMPLANTATION IS CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 15494466 ↗
• MalfunctionSep 12, 2022Migration; Migration

  THE USER UNDERWENT A REVISION SURGERY TO REPOSITION THE DEVICE, DURING WHICH THE DEVELOPMENT OF A CHOLESTEATOMA WAS VERIFIED. IT WAS THEN DECIDED TO EXPLANT THE DEVICE.

  Patient problems: Failure of Implant

  MAUDE report 15402125 ↗
• MalfunctionFeb 21, 2022Output Problem; Output Problem

  HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED.

  Patient problems: Failure of Implant

  MAUDE report 13568738 ↗
• InjuryMar 25, 2021Output Problem; Output Problem

  IN SITU MEASUREMENTS SHOW ABNORMAL RESULTS.

  Patient problems: Failure of Implant

  MAUDE report 11567700 ↗
• InjuryMar 22, 2021Output Problem; Output Problem

  THE RECIPIENT HAD EXPERIENCED A DECREASING OF THE HEARING IMPRESSION FOR APPROXIMATELY HALF A YEAR. THE RECIPIENT ALSO REPORTED UNPLEASANT PRESSURE SENSATION OVER THE IMPLANT AREA WHEN WEARING THE AUDIO PROCESSOR. REPORTEDLY, THE MAGNET STRENGTH SEEMED TO BE APPROPRIATE WITHOUT BEING TOO STRONG AND THERE WAS NO VISIBLE SWELLING OR SKIN REACTION. THE RECIPIENT HAS BEEN RE-IMPLANTED ON (B)(6) 2021.

  Patient problems: Failure of Implant

  MAUDE report 11540682 ↗
• InjuryFeb 3, 2021Migration; Migration

  IT HAS BEEN REPORTED A MIGRATION OF THE ELECTRODE ARRAY AND ELECTRODES FROM SEVEN TO TWELVE ARE OUT OF COCHLEA. THE USER HAS BEEN EXPLANTED ON (B)(6) 2021.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 11271478 ↗
• InjuryFeb 7, 2020Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. IT IS REPORTED THAT THE PATIENT DID NOT PRESENT ANY RESPONSES IN THE FREE FIELD AUDIOMETRY (NOT ABLE TO DETECT LOUD SOUNDS).

  Patient problems: Failure of Implant

  MAUDE report 9680465 ↗
• InjuryNov 5, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  SINCE IMPLANTATION, THE RECIPIENT HADN'T SHOWED ANY CLEAR ADVANCEMENT WITH THE DEVICE. THERE WAS NO CLEAR RESPONSE TO THE DEVICE ACCORDING TO REHABILITATION INFORMATION. ON (B)(6)2019 A SMALL BUMP WAS SEEN OVER HER SCAR. THE RECIPIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019. REPORTEDLY, THE RECIPIENT WAS RE-ACTIVATED WITH GOOD RESULTS.

  Patient problems: Foreign Body Reaction; Inflammation

  MAUDE report 9279043 ↗
• MalfunctionApr 7, 2019Adverse Event Without Identified Device or Use Problem; Output Problem; Adverse Event Without Identified Device or Use Problem; Output Problem

  USER REPORTED A DECREASED IN HEARING PERFORMANCE WITH THE DEVICE FOLLOWING A CAR ACCIDENT ON THE IN (B)(6) 2019. THE USER WAS HIT HARD FROM BEHIND RESULTING IN SWELLING OVER THE FACE. SHE WAS ALSO TREATED FOR A MIDDLE EAR INFECTION. AS PER NEW INFORMATION, USER'S HEARING PERFORMANCE IS CURRENTLY GOOD FOLLOWING THE RESOLUTION OF THE SWELLING.

  Patient problems: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 8489963 ↗
• InjuryDec 5, 2018Output Problem; Output Problem

  THE USER EXPERIENCED A SUDDEN LOSS OF SOUND WITH THE DEVICE. IN THE FOLLOWING FEW DAYS THE DEVICE WOULD WORK INTERMITTENTLY. ON THE THIRD DAY, AFTER 3-4 HOURS OF USE, HE HAD AN UNCOMFORTABLE PINCHING FEELING IN HIS EAR AND FACIAL NERVE STIMULATION. THIS WAS FOLLOWED BY A TINNITUS THAT CHANGED FROM HIGH PITCHED TO LOW PITCHED. NO TRAUMA OR ACCIDENT IS REPORTED.

  Patient problems: Failure of Implant; Tinnitus; Undesired Nerve Stimulation

  MAUDE report 8132359 ↗

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