Medtronic Has a Serious Battery-Related Recall

The medical device giant is recalling thousands of battery packs used in certain patient monitors.

Chris Newmarker

FDA recently issued a Class I designation over a Medtronic recall of battery packs used with the Capnostream 20 and Capnostream 20p patient monitors.

The battery packs--9817 across the United States--could pose a potential fire hazard, according to FDA.

Medtronic says it has received seven reports of battery damage related to heat, including one case in which a battery fire resulted in smoke inhalation and minor burns. 

The recall involves model numbers 016400 and 010520, with manufacturing dates between April 1, 2014 and February 3, 2016 and distribution dates between April 1, 2014 to February 3, 2016.

The monitors are used to track vital signs, as well as oxygen and carbon dioxide levels, in patients. 

Medtronic Respiratory & Monitoring Solutions is blaming a manufacturing defect for causing the temperature increase in the eight-cell, 14.3-volt, lithium ion battery pack , which could then potentially cause a fire. An undisclosed third-party contract manufacturer made a manufacturing change that likely caused the defect. Medtronic now has a new contract manufacturer making batteries that meet the original specifications. 

The company sent an "Urgent: Medical Device Recall" letter to affected customers on April 15, asking the customers to remove and destroy the battery packs--including with instructions about how to do so.

This is the first Medtronic recall to make it onto FDA's list of serious medical device recalls this year. 

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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