Reported Jul 24, 2024 · Ongoing

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

MED-EL Elektromedizinische Gereate, GmbH

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MED-EL Elektromedizinische Gereate, Gmbh · Furstenweg 77a · Innsbruck · N/A

Is this the product you have?

  • Mi1250 SYNCHRONY 2
  • Item Numbers
    • a) 39541
    • FLEXSOFT S-Vector
    • b) 39545
    • FLEX28 S-Vector
    • c) 39547
    • FLEX26 S-Vector
    • Cochlear Implant
Lot codes and dates
    • 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
Amount recalled
7 devices

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.