Mi1000 MED-EL CONCERT +FLEX26 36615Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 09008737366155), received between Dec 6, 2021 and Jul 15, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Device 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

  IT WAS REPORTED THAT THE USER PRESENTED A SIGNIFICANT CASE OF INFECTION IN THE RIGHT EAR, AND THERE WAS ALSO EXTRUSION OF THE ELECTRODE ARRAY.

  Patient problems: Ear infection; Skin Tears

  MAUDE report 22506722 ↗
• MalfunctionApr 17, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. REIMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 19123350 ↗
• MalfunctionJan 10, 2024Impedance Problem; Impedance Problem

  THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER A SEVERE TRAUMA. THE PARENTS REPORTED THAT THE USER FELL FROM A HIGH ALTITUDE. RE-IMPLANTATION IS CONSIDERED. NO DATE HAS BEEN SCHEDULED YET.

  Patient problems: Failure of Implant

  MAUDE report 18481826 ↗
• MalfunctionOct 17, 2022Impedance Problem; Output Problem; Impedance Problem; Output Problem

  THE USER CAN NO LONGER HEAR WITH THE LEFT SIDE DEVICE. IN SITU TESTING SHOWED AFFECTED CHANNELS. A REIMPLANTATION IS CONSIDERED.

  Patient problems: Failure of Implant

  MAUDE report 15614130 ↗
• MalfunctionDec 6, 2021Output Problem; Output Problem

  THE USER'S HEARING PERFORMANCE HAS WORSENED OVER THE PAST FEW MONTHS. THE USER HAS BEEN RE-IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 12933520 ↗

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
• 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