Certain Medtronic Capnostream Monitors Pose Thermal Damage Hazard
Image: NCCC

Certain Medtronic Capnostream Monitors Pose Thermal Damage Hazard

The company has received seven reports of damage, including one involving a fire

April 20, 2016

A malfunctioning battery has triggered a worldwide recall from Medtronic.

The medical technology company is recalling the battery pack used in its Covidien Oridion labeled Capnostream 20 and Capnostream 20p Patient Monitors. The heat from the battery can increase to a dangerous level, exposing consumers to a risk of thermal damage.

Capnostream monitors are external (non-implantable) medical devices used to assess patients' respiratory status and identify changes in breathing. The prescription device is operated by trained healthcare professionals in a clinical setting and in the home.

The recalled items were produced by a contract manufacturer between April 2014 and February 2016. These affected packs bear a model number between 016400 and 010520.

Medtronic has received seven reports of thermal damage out of about 10,000 impacted battery packs. Of these seven reports, one involved a fire resulting in smoke inhalation and minor burns.

The company has identified a manufacturing change conducted by the third party contract manufacturer as the probable cause of the hazard and is manufacturing new batteries to fit its needs.

The company recommends that customers use the Capnostream monitors on AC power (with the battery pack removed) until a replacement battery pack is available. Medtronic will supply new batteries to affected customers when available.

Consumers with questions about this recall can contact Medtronic by phone at (800) 635-5267.