Mi1250 SYNCHRONY 2, Item Numbers recallZ-2356-2024 · MED-EL Elektromedizinische Gereate, Gmbh · initiated Apr 18, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MED-EL Elektromedizinische Gereate, Gmbh or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
MED-EL issued an Urgent-Medical Device Field Safety Notice (FSN) Medical Device Return notice to its sole US consignee (distributor) on 04/18/2024 via email. The notice explained the problem with the device and requested the return of all affected devices.
Recall details
- Recall number
- Z-2356-2024
- Status
- Open, Classified
- Initiated by the company
- Apr 18, 2024
- Posted by the FDA
- Jul 12, 2024
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Quantity
- 7 devices
- Product code
- MCM
- FDA submissions
- P000025
- Distribution
- US, Durham, NC
Product description
Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Code information (models, lots, serial numbers)
a) 39541, UDI/DI 09008737395414, Serial Numbers: 859106; b) 39545, UDI/DI 09008737395452, Serial Numbers: 860731, 860782, 863380; c) 39547, UDI/DI 09008737395476, Serial Numbers: 860757, 860772, 863386
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Mi1250 SYNCHRONY 2 FLEX28 S-Vector Magnet 39545Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear1 recall307 reports
- Mi1250 SYNCHRONY 2 FLEXsoft S-Vector Magnet 39541Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear1 recall42 reports
- Mi1250 SYNCHRONY 2 FLEX26 S-Vector Magnet 39547Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear1 recall34 reports
Other devices under the same FDA submission
105 devices cleared under P000025 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SONATATI100 +STANDARD 04911Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear693 reports
- Mi1200 SYNCHRONY +FLEX28 09404Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · IMPLANT, COCHLEAR672 reports
- SONATATI100 +FLEX28 08361Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear427 reports
- Mi1000 MED-EL CONCERT +FLEX28 08363Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear406 reports
- Mi1210 SYNCHRONY ST +STANDARD 33182Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear321 reports
- Mi1200 SYNCHRONY PIN +FLEX28 09405Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · IMPLANT, COCHLEAR287 reports
- SONATATI100 +FLEXsoft 04917Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear182 reports
- Mi1210 SYNCHRONY ST +FLEX28 33187Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear141 reports
- Mi1000 MED-EL CONCERT +STANDARD 06268Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear112 reports
- Mi1200 SYNCHRONY +FLEX24 09400Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · IMPLANT, COCHLEAR111 reports
- Mi1250 SYNCHRONY 2 FLEX28 36682Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear108 reports
- FineTuner Echo 34429Med-El Elektromedizinische Geräte Gesellschaft m.b.H. · Implant, Cochlear105 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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