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FDAnews Device Daily Bulletin

Medtronic Recalls Battery Pack

April 21, 2016

Following reports of manufacturing defects, Medtronic is recalling its battery pack used in its Covidien Oridion labeled Capnostream 20 and -20p patient monitors due to the potential risk of thermal damage.

The company has received seven reports of problems associated with the packs, one of which included a fire that resulted in minor burns and smoke inhalation, according to the company.

The worldwide recall affects 9,817 battery packs, involving model numbers 016400 and 010520, manufactured between April 2014 and February 2016.

Medtronic notified customers last Friday and has sent out rework kits along with instructions for removal and proper disposal of the affected devices. — Anisa Jibrell