The devices are being recalled due to a defect causing an increased risk of thermal damage in the packs.
Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
Capnostream monitors are external devices used to assess respiratory status and identify changes in breathing, the Fridley, Minn.-based company said, and are used in both clinical and home settings.
The voluntary recall affects 9,817 battery packs with model numbers 016400 and 010520 manufactured by a contract manufacturer between April 2014 and February 2016. The packs were distributed nationwide, including Washington D.C., the FDA said.
In April, Medtronic initiated the voluntary recall and said it had received 7 reports of thermal damage out of the 9,817 battery packs affected by the field action, with 1 report involving a fire that resulted in smoke inhalation and minor burns, according to a press release.
The medtech giant sent a letter to customers with affected units along with a rework kit with full instructions for removal and disposal or recycling of the affected battery packs.
Medtronic said it recommended customers use the Capnostream monitors on AC power with the pack removed until a replacement battery is available.
Medtronic said it identified a manufacturing change conducted by the 3rd party contract manufacturer as the root cause and is manufacturing new batteries to meet the original specifications with a new contract manufacturers, which will be supplied to affected customers when available.