|Medtronic's Covidien Oridion Capnostream20p--Courtesy of Medtronic|
Medtronic ($MDT) is voluntarily recalling a battery pack used in some of its patient monitors due to a manufacturing defect, adding another piece of bad news to its recent string of woes.
The Dublin-based device giant found a battery manufacturing defect that "may increase the risk of thermal damage" in the battery pack, the company said in a statement. So it's recalling packs manufactured between April 2014 and February 2016. The packs are used in its Covidien Oridion labeled Capnostream20 and Capnostream20p patient monitors, which keep tabs on patients' respiratory status and flag changes in breathing.
Medtronic initiated the recall after getting 7 reports of thermal damage out of 9,817 battery packs. One report "involved a fire resulting in smoke inhalation and minor burns," the company said.
Last week, the company sent a letter to customers who have battery packs affected by the recall. Medtronic also sent out a rework kit with instructions about how to remove and dispose of the old battery packs, which are made by third-party contract manufacturers.
The company thinks that the "probable root cause" of the issue is a "manufacturing change conducted by the third party contract manufacturer." Medtronic has a new contract manufacturer and is making new batteries that are up to snuff.
Until customers get the new battery packs, they should dispose of the old ones and use Capnostream monitors on AC power, Medtronic said in a statement. "No other Medtronic products are affected by this supplier of battery packs," the company said.
Meanwhile, Medtronic "has contacted the FDA and other regulatory bodies to share information related to this issue," the company said. It "will continue working directly with government authorities and customers on this voluntary recall."
The news comes during a dark hour for Medtronic. Last week, the company came under fire for shutting down a study of its bone graft, Infuse, and allegedly tucking away some unsavory evidence. Medtronic has taken some responsibility for mishandling the study, but is still defending its actions to the public and the industry.
- read the statement