Mi1000 MED-EL CONCERT +FLEX28 08363Recalls & reported problems
Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This MED-EL Concert FLEX28 cochlear implant is an implant that helps restore hearing. Its 403 adverse event reports often describe output and electrical impedance problems, the implant shifting, and implant failure, and some describe hearing being affected and devices being removed. The reports include no deaths and 158 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 406
- Deaths reported
- 0
- Injuries reported
- 160
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 406 adverse event reports that list this exact device (DI 09008737083632), received between Sep 16, 2016 and Sep 15, 2026 — classified as 160 injuries, 246 malfunctions.
The most frequently reported specific device problem is “Output Problem” (204 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.
Reports received per month
Most reported problems
Device problems
- Output Problem204
- Impedance Problem138
- Migration51
- Circuit Failure19
- Device Appears to Trigger Rejection19
- Adverse Event Without Identified Device or Use Problem17
- Insufficient Device Problem Information17
- Device Handling Problem4
Patient problems
- Failure of Implant316
- No Clinical Signs, Symptoms or Conditions60
- Head Injury44
- Insufficient Information9
- Skin Tears8
- Tissue Breakdown8
- Pain5
- Tissue Damage5
Recent adverse event reports
The 25 most recent of 406 reports, in the reporter's own words as published by the FDA.
InjurySep 15, 2026Device Appears to Trigger Rejection
In (b)(6) 2025, the user developed edema and swelling at the right cochlear implant incision site.The user was explanted.
Patient problems: Skin Tears
MAUDE report 50767291 ↗MalfunctionSep 1, 2026Impedance Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541087 ↗InjurySep 1, 2026Impedance Problem
In situ measurements show a gradual increase of channels with high impedance since 2018.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50539403 ↗MalfunctionJun 30, 2026Circuit Failure
THE DEVICE WAS EXPLANTED.
Patient problems: Head Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 25662907 ↗MalfunctionJun 23, 2026Migration
THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25594097 ↗MalfunctionJun 5, 2026Circuit Failure
THE HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.
Patient problems: Head Injury
MAUDE report 25406231 ↗MalfunctionMay 27, 2026Impedance Problem
THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25298955 ↗MalfunctionMay 11, 2026Impedance Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Patient problems: Rhinitis; Undesired Nerve Stimulation
MAUDE report 25134291 ↗MalfunctionMay 7, 2026Impedance Problem
MalfunctionApr 9, 2026Impedance Problem
THE USER RECENTLY SUFFERED A FALL AND SOME SCARRING IS KNOW SEEN AROUND THE INCISION SITE. RE-IMPLANTATION IS BEING CONSIDERED.
Patient problems: Head Injury
MAUDE report 24832410 ↗MalfunctionApr 3, 2026Impedance Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24780998 ↗MalfunctionApr 3, 2026Impedance Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24773209 ↗MalfunctionMar 10, 2026Impedance Problem
THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24555976 ↗MalfunctionFeb 25, 2026Migration
THE DEVICE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24440315 ↗MalfunctionFeb 24, 2026Impedance Problem; Migration
THE HEARING PERFORMANCE OF THE USER'S RIGHT IMPLANT HAS DECREASED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427754 ↗MalfunctionFeb 17, 2026Impedance Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24362433 ↗MalfunctionFeb 12, 2026Device Dislodged or Dislocated
THE DEVICE WAS EXPLANTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24320480 ↗MalfunctionFeb 4, 2026Impedance Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Patient problems: Head Injury
MAUDE report 24258338 ↗MalfunctionFeb 4, 2026Circuit Failure; Impedance Problem
THE HEARING PERFORMANCE OF THE DEVICE IS AFFECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258327 ↗InjuryJan 26, 2026Device Appears to Trigger Rejection
A SKIN WOUND HAD DEVELOPED, LEAVING THE IMPLANT EXPOSED.
Patient problems: Tissue Breakdown
MAUDE report 24176338 ↗InjuryJan 20, 2026Device Appears to Trigger Rejection
THE DEVICE EXTRUDES THROUGH THE SKIN. THIS REPORT REFERS TO 9710014-2026-00040. FOR FURTHER INFORMATION PLEASE REFER TO THIS REPORT.
Patient problems: Tissue Breakdown
MAUDE report 24116541 ↗InjuryJan 20, 2026Device Appears to Trigger Rejection
THE DEVICE EXTRUDES THROUGH THE SKIN. DUE TO FAILURE OF MEDICAL CLEARANCE FROM ANESTHESIA THE EXPLANTATION SURGERY WAS CANCELLED AND WILL BE RESCHEDULED.
Patient problems: Tissue Breakdown
MAUDE report 24115670 ↗MalfunctionDec 24, 2025Migration; Migration
THE DEVICE WAS EXPLANTED DUE TO ELECTRODE MIGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23886384 ↗MalfunctionDec 23, 2025Migration; Migration
THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. REVISION SURGERY IS CONSIDERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23876711 ↗MalfunctionDec 16, 2025Lack of Effect; Lack of Effect
AFTER A FALL WITH IMPACT ON THE LEFT FOREHEAD, THE USER HAD SOUND QUALITY ISSUES WITH AND WITHOUT USE OF THE PROCESSOR. ADDITIONAL PROGRAMMING ADJUSTMENTS WERE MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23815477 ↗
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, ClassifiedMi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
- Z-2137-2019 · Oct 16, 2018 · TerminatedMED 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 · TerminatedMED 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 · TerminatedMED 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
Other Implant, Cochlear devices
- HiRes™ Ultra CI HiFocus™ MS Electrode CI-1600-04Advanced Bionics AG · Implant, Cochlear2,918 reports
- Cochlear® Nucleus® CI512 cochlear ImplantCochlear Limited · IMPLANT, COCHLEAR2,771 reports
- Cochlear® Nucleus® CI622 cochlear Implant with Slim Straight electrodeCochlear Limited · Implant, cochlear2,115 reports
- Cochlear® Nucleus® CI632 cochlear Implant with Slim Modiolar electrodeCochlear Limited · Implant, cochlear2,057 reports
- Nucleus Z60353Cochlear Limited · IMPLANT, COCHLEAR2 deaths1,815 reports
- Cochlear® Nucleus® CI522 cochlear Implant with Slim Straight electrodeCochlear Limited · IMPLANT, COCHLEAR1,475 reports
- Cochlear® Nucleus® CI612 cochlear ImplantCochlear Limited · Implant, cochlear1,150 reports
- Nucleus Z190574Cochlear Limited · IMPLANT, COCHLEAR981 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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