FDA: Medtronic recalls battery pack used on patient monitors because of fire risk

Editor's Note

The Food and Drug Administration (FDA) on May 27 classified the recall by Medtronic of its Capnostream 20 and Capnostream 20p patient monitor battery packs as Class I, the most serious.

The recall is being initiated because a manufacturing defect causes an increase in temperature in the battery that may cause a fire in the system monitor.

The recall affects model numbers 016400 and 010520.

Posted 05/27/2016] AUDIENCE: Risk Manager, Patient ISSUE: Medtronic Respiratory & Monitoring Solutions is recalling the battery packs due to a manufacturing defect that causes an increase in temperature within battery that may cause a fire in the system monitor. The use of affected products may cause serious adverse health consequences, including death.