Medtronic is notifying customers worldwide of a voluntary recall for the battery pack used in its Covidien Oridion-labeled Capnostream 20 and Capnostream 20p patient monitors. The voluntary recall is being conducted because of a battery manufacturing defect that may increase the risk of thermal damage in the battery pack. The scope of this recall includes battery pack model numbers 016400 and 010520, which were made by a contract manufacturer between April 2014 and February 2016.
Capnostream monitors are external (nonimplantable) medical devices used to assess patients’ respiratory status and to identify changes in breathing. The prescription device is operated by trained health care professionals in a clinical setting and in the home.
Medtronic has received seven reports of thermal damage out of 9,817 battery packs affected by this field action. Of these seven reports, one involved a fire resulting in smoke inhalation and minor burns.
On April 15, Medtronic sent a letter to customers who have Capnostream battery packs affected by this voluntary recall. The company also supplied a rework kit with full instructions for the removal and proper disposal or recycling of the battery pack according to local policy. The eight-cell, 14.3-volt lithium ion battery pack is custom-manufactured by a third-party contract manufacturer.
Medtronic recommends that customers use the Capnostream monitors on AC power (with the battery pack removed) until a replacement battery pack is available.
The company has identified a manufacturing change imposed by the third-party contract manufacturer as the probable root cause and is making new batteries that meet original specifications with a new contract manufacturer. Medtronic will supply new batteries to affected customers when available. No other Medtronic products are affected by this supplier of battery packs.
Medtronic has contacted the FDA and other regulatory bodies to share information related to this issue.
Source: FDA; April 20, 2016.