Medtronic Recall for Respiratory Monitoring Battery Pack

A worldwide voluntary recall for the battery pack used in Medtronic’s Covidien Oridion labeled Capnostream 20 and Capnostream 20p Patient Monitor is being conducted due to a manufacturing defect that may increase the thermal damage in the battery pack. Battery pack model number S016400 and 010520 were manufactured between April 2014 and February 2016 reports the U.S. Food and Drug Administration (FDA).

Capnostream monitors are used to identify changes in breathing and are external medical devices to assess respiratory status. They are available by prescription and used by trained health care providers in a clinical setting or in the home.

Seven reports of thermal damage out of 9,817 battery packs were affected. One of these incidents involved a fire that resulted in minor burns and smoke inhalation, the FDA reports.

A letter was sent on April 16, 2016 by Medtronic to customers affected by the recall. The company provided a kit with instructions for the removal and proper disposal of the battery pack. The 14.3 eight cell Lithium ion battery pack is manufactured by third party manufacturers, the FDA reports.

It is recommended by Medtronic that consumers use the Capnostream monitors on AC power, with the batter pack taken out, until the replacement battery pack is available.

The probable root cause has been identified by Medtronic and is manufacturing new batteries with a new contract manufacturer that will meet original specifications. New batteries will be supplied to affected customers when available. No other Medtronic products by this supplier of battery packs are affected.

The FDA has been contacted by Medtronic and other regulatory groups to share information on this issue. Medtronics will continue cooperating with government agencies and customers relating to this voluntary recall, the FDA reports.

This entry was posted in Defective Medical Devices, Recalled Medical Devices. Bookmark the permalink.

© 2005-2020 Parker Waichman LLP ®. All Rights Reserved.