Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Mi1250 SYNCHRONY 2 Recalled by MED-EL Elektromedizinische Gereate, Gmbh Due to A small number of devices may have a...

Date: April 18, 2024
Company: MED-EL Elektromedizinische Gereate, Gmbh
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact MED-EL Elektromedizinische Gereate, Gmbh directly.

Affected Products

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

Quantity: 7 devices

Why Was This 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.

Where Was This Sold?

This product was distributed to 1 state: NC

Affected (1 state)Not affected

About MED-EL Elektromedizinische Gereate, Gmbh

MED-EL Elektromedizinische Gereate, Gmbh has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report