Covidien (NYSE:COV) said it’s recalling some of its Pipeline and Alligator brain embolism devices after internal testing revealed a potentially lethal problem with the guidewires used to deliver them.
Mansfield, Mass.-based Covidien said it hasn’t received any reports of injuries related to the problem, in which the plastic coating applied to the guidewire can delaminate and detach from the devices. The coating, made of polytetrafluoroethylene, is designed to reduce friction between the devices and the guidewire, according to a press release.
"Delamination of the PTFE coating could potentially lead to embolic occlusion in the cerebral vasculature with the risk of stroke and/or death," Covidien said. "A total of 32 Pipeline embolization devices and 621 Alligator retrieval devices are affected by this recall."
Covidien said it alerted customers April 1 about the recalled devices, which were made and sold from May 2013 to March 2014. The affected Pipeline devices were sold in the U.S., Australia, France, Germany and the U.K., according to the release. The affected Alligator devices were sold in the U.S., Australia, Canada, Europe and Latin America, Covidien said. The recalled products are slated to be replaced, the company said.
Covidien alerted customers to the recall by letter on April 1, 2014, and is arranging for replacement of the recalled products. The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.
Covidien acquired the Pipeline device when it bought eV3 in the summer of 2010 for $2.6 billion in cash. Pipeline won FDA approval in March 2011.