FDA Medical Device Recalls (openFDA)
MED-EL Elektromedizinische Gereate, Gmbh: Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
- Recall number
- Z-2356-2024
- Recalling firm
- MED-EL Elektromedizinische Gereate, Gmbh
- Product
- Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
- Status
- Open, Classified
- Initiated
- 2024-04-18
- Posted
- 2024-07-12
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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.
- Quantity
- 7 devices
- Distribution
- US, Durham, NC
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P000025"]
- Product code
- MCM
- Firm FEI
- 3000249315
- Firm city
- Innsbruck
- Firm state
- not on file
- Firm country
- Austria
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28