Covidien said April 11 that internal testing revealed a potentially lethal problem with the guidewires used to deliver the devices, but that it hasn’t received any reports of injuries related to the problem.
Some lots of the Pipeline and Alligator devices could have the plastic coating applied to the guidewire 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 at the time. "A total of 32 Pipeline embolization devices and 621 Alligator retrieval devices are affected by this recall."
Today the FDA gave the recall its most serious label, Class I, for "situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death."
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 is arranging for replacement of the recalled products. Covidien acquired the Pipeline device when it bought eV3 in the summer of 2010 for $2.6 billion in cash. The Pipeline device won FDA approval in March 2011.