Mi1260 SONATA 2 FLEXsoft 38541Recalls & reported problems
Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09008737385415), received between Feb 25, 2026 and May 18, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Migration2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Undesired Nerve Stimulation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Migration
THE USER IS NOT SATISFIED WITH THE HEARING PERFORMANCE OF THE DEVICE.
Patient problems: Undesired Nerve Stimulation
MAUDE report 25197419 ↗MalfunctionFeb 25, 2026Migration
THE CHILD HAS MADE NO PROGRESS WITH THE IMPLANT. THE USER HAS BEEN RE-IMPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24441504 ↗
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 Product
- 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. Mi1000 CONCE
- 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
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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