Mi1210 SYNCHRONY ST +FLEX20 33191Recalls & 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
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09008737331917), received between Jun 4, 2025 and Jun 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE USER WA RE-IMPLANTED ON (B)(6) 2025 ACCORDING TO SKIN PROBLEMS. FURTHER INFORMATION IS REQUESTED FROM THE FIELD.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 22138989 ↗
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-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
- 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
Other Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification devices
- Nucleus Z60988Cochlear Limited · Hybrid cochlear implant199 reports
- Mi1250 SYNCHRONY 2 FLEX24 S-Vector Magnet 39543Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification23 reports
- Mi1250 SYNCHRONY 2 FLEX24 36680Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification17 reports
- Mi1200 SYNCHRONY +FLEX20 07880Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification8 reports
- Mi1210 SYNCHRONY ST +FLEX24 33186Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification7 reports
- Mi1250 SYNCHRONY 2 PIN FLEX24 S-Vector Magnet 39542Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification6 reports
- Mi1250 SYNCHRONY 2 FLEX20 37175Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification4 reports
- Mi1250 SYNCHRONY 2 FLEX34 S-Vector Magnet 41544Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Cochlear Implant With Combined Electrical Stimulation And Acoustic Amplification3 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.
How reports and recalls are matched · Editorial policy · Report an error on this page