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Open, Classified

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

FDA Recall Z-2356-2024 · Posted 2024-07-12

Recalling FirmMED-EL Elektromedizinische Gereate, Gmbh
Recall StatusOpen, Classified
Product CodeMCM
Date Initiated2024-04-18
Product Quantity7 devices

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US, Durham, NC

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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