Mi1250 SYNCHRONY 2 FLEX28 S-Vector Magnet 39545Recalls & 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
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This MED-EL SYNCHRONY 2 is a cochlear hearing implant. Many of its 287 reports describe electrodes moving out of place and electrical problems, and some describe reimplantation, skin breakdown and infection. The reports include 116 injuries and no deaths. One open recall began in April 2024 and concerns a small number of devices that may crack internally and stop working.
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
- 307
- Deaths reported
- 0
- Injuries reported
- 130
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 307 adverse event reports that list this exact device (DI 09008737395452), received between Nov 16, 2020 and Sep 29, 2026 — classified as 130 injuries, 177 malfunctions.
The most frequently reported specific device problem is “Migration” (93 reports).
1 FDA recall record name this device's identifier, 1 still open.
3 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
Recalls naming this device
- Apr 18, 2024Class IIOpen, Classified
A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
Z-2356-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Migration93
- Impedance Problem72
- Adverse Event Without Identified Device or Use Problem57
- Device Appears to Trigger Rejection55
- Microbial Contamination of Device17
- Output Problem15
- Circuit Failure13
- Device Handling Problem9
Patient problems
- Failure of Implant97
- No Clinical Signs, Symptoms or Conditions85
- Tissue Breakdown24
- Skin Tears23
- Unspecified Infection18
- Bacterial Infection16
- Insufficient Information10
- Post Operative Wound Infection10
Recent adverse event reports
The 25 most recent of 307 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Migration
The user reported difficulties with speech understanding and the presence of crackling sounds with the implant after initially satisfactory results. A surgical intervention is planned for (b)(6) 2026 to reposition the electrodes.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929170 ↗MalfunctionSep 28, 2026Circuit Failure
Hearing performance with the device is affected.
Patient problems: Head Injury
MAUDE report 50912654 ↗InjurySep 25, 2026Impedance Problem
Hearing performance with the device is affected. Further tests will be performed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895628 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Explantation due to wound infection. One year after implantation wound infection occurred. The wound was revised in (b)(6)2026. In (b)(6) 2026 the wound opened up again.
Patient problems: Wound Infection
MAUDE report 50867077 ↗MalfunctionSep 23, 2026Impedance Problem
Hearing performance with the device is affected. Non auditory stimulation is reported with loud noises.
Patient problems: Inappropriate Device Stimulation of Tissue
MAUDE report 50864475 ↗InjurySep 22, 2026Device Appears to Trigger Rejection
A wound-healing disorder developed at the posterior edge of the implant, resulting in skin penetration and exposure of the implant. The user was explanted.
Patient problems: Skin Tears
MAUDE report 50855840 ↗InjurySep 22, 2026Malposition of Device; Migration
The electrode has completely migrated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851657 ↗MalfunctionSep 15, 2026Impedance Problem
In-package measurement failed for electrode 3 in the operation room. The device was not used and the user implanted with another device.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771629 ↗MalfunctionSep 15, 2026Migration
Hearing perception with the device is affected.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50768968 ↗InjurySep 10, 2026Migration
The user underwent explanation following an infection that resulted in migration of the electrode array.
Patient problems: Unspecified Infection
MAUDE report 50709947 ↗MalfunctionSep 3, 2026Impedance Problem
Hearing performance with the device is affected.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50588326 ↗InjurySep 2, 2026Migration
User has a non-healing wound at the incision site. Hearing performance with the device has been affected. This report refers to 9710014-2026-00815. For further information please refer to this report.
Patient problems: Post Operative Wound Infection
MAUDE report 50562718 ↗InjurySep 2, 2026Migration
User has a non-healing wound at the incision site. Hearing performance with the device has been affected.
Patient problems: Post Operative Wound Infection
MAUDE report 50560643 ↗InjurySep 1, 2026Device Appears to Trigger Rejection
The electrode lead migrated into the EAC. The user was reimplanted with a new device.
Patient problems: Skin Tears
MAUDE report 50538748 ↗MalfunctionAug 27, 2026Circuit Failure
Hearing performance with the device is affected.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50470621 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
The user is experiencing non-auditory sensations with device stimulation, present at activation. Both pain and discomfort is noted. No auditory perception is noted without discomfort. 4 days post implantation left sided facial paralysis started. At most recent follow-up the user had minimal auditory percepts on a few electrodes. Her facial nerve function has not returned.
Patient problems: Facial Paralysis; Pain
MAUDE report 50470619 ↗InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem
The user is experiencing non-auditory sensations with device stimulation, present at activation. Both pain and discomfort is noted. No auditory perception is noted without discomfort. 4 days post implantation left sided facial paralysis started, which has not resolved so far. This report refers to 9710014-2026-00793. For further information please refer to this report.
Patient problems: Facial Paralysis
MAUDE report 50470618 ↗InjuryAug 20, 2026Device Appears to Trigger Rejection
Device has extruded through the skin flap. There was also an infection. Additionally, there was a partial migration of the electrode out of cochlea. Hearing performance with the device is also affected.
Patient problems: Tissue Breakdown
MAUDE report 50338450 ↗InjuryAug 19, 2026Device Appears to Trigger Rejection
Device has extruded through the skin flap. There was also an infection. Additionally, there was a partial migration of the electrode out of cochlea. Hearing performance with the device is also affected. For further information please refer to this report.
Patient problems: Tissue Breakdown
MAUDE report 50321620 ↗InjuryAug 10, 2026Migration
At switch on sound quality with the device overall was poor. The implant was re-inserted and re-positioned successfully. In addition, it was confirmed once the skin was opened that the implant package had slipped down.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50189741 ↗InjuryAug 5, 2026No Device Output; Migration
The electrode has completely migrated.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50139718 ↗InjuryAug 5, 2026Migration
The hearing performance decreased and imaging confirmed an electrode extrusion. Re-Implantation will be done on (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50137650 ↗MalfunctionJul 30, 2026Migration
A CI Scan confirmed the electrode had migrated about a third out of the cochlea. The surgeon plans to revise with the same implant, but with a back-up ready, if needed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50081623 ↗InjuryJul 30, 2026Migration
There is concern of migration of the implant.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50081099 ↗InjuryJul 28, 2026Migration
The audiologist reported that the user's receiver/stimulator has migrated downwards and that imaging shows numerous electrodes to be extra-cochlear. Revision surgery is planned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50054502 ↗
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-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
- 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
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 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page