Z-2356-2024Class II

Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26...

Name: Z-2356-2024 Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26...
Creator: MED-EL Elektromedizinische Gereate, Gmbh
Published: 2024-04-18
License: https://open.fda.gov/license/

Med-el Elektromedizinische Geraete, GmbH / initiated 2024-04-18 / Open, Classified / root cause: manufacturing process

FDA source

MED-EL Elektromedizinische Gereate, Gmbh began a recall of Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant on 2024-04-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2356-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-18
Posted: 2024-07-12
Recalling firm: Med-el Elektromedizinische Geraete, GmbH
Product: Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vector; Cochlear Implant
Product code: MCM Implant, Cochlear
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 7 devices
Distribution: US, Durham, NC
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2356-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2356-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-24	2024-07-12

Product code MCM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)