Medtronic PLC is recalling about 9,800 batteries used in patient bedside breathing monitors worldwide after one unit overheated and caught on fire, causing minor injuries.
The prescription-only Covidien Oridion Capnostream 20 and Capnostream 20p patient monitors are used in clinical settings and in the home to assess patients’ respiratory status and changes in breathing.
In a voluntary recall notice publicized by the company and regulators on Wednesday, Medtronic recommended removing and properly disposing of the eight-cell, 14.3-volt lithium ion battery packs. The patient monitors will continue to work on AC power with the batteries removed, until a replacement battery pack is available.
Medtronic said a third-party contractor manufactured the batteries. A root-cause analysis identified a manufacturing change by the outside company as the probable cause of the problem affecting batteries produced between April 2014 and February 2016.
The unidentified company is supplying new batteries to affected customers when they are available. No other Medtronic products are affected.
Of the 9,817 battery packs affected by the recall, Medtronic said it received seven reports of “thermal damage,” including one that involved a fire that resulted in smoke inhalation and minor burns.