Device maker Covidien has recalled some of its Pipeline and Alligator brain embolism devices after discovering a potentially lethal problem with the devices’ guidewires.
Covidien identified a problem in the plastic coating on the device’s guidewire; the coating can delaminate and detach from the device, MassDevice.com reports. In a company press release Covidien explained, “Delamination of the PTFE coating could potentially lead to embolic occlusion [blockage] in the cerebral vasculature with the risk of stroke and/or death.” Covidien says that, to date, it has not received any reports of injuries related to the problem. The company has informed the U.S. Food and Drug Administration (FDA) and other regulatory agencies of the recall.
The Pipeline Embolization Device is used for treatment of adults (22 years of age and older) with large or giant wide‐necked intracranial aneurysms in the internal carotid artery, and the Alligator Retrieval Device is used in the peripheral and neuro‐vasculature for foreign body retrieval, according to Covidien’s press release.
The recall includes 32 Pipeline embolization devices and 621 Alligator retrieval devices. These devices were made and sold between May 2013 and March 2014. Covidien alerted customers about the recall on April 1, MassDevice reports, and the company is arranging replacement of the recalled devices. The Pipeline devices were sold in the U.S., Australia, France, Germany and the U.K.; the Alligator devices were sold in the U.S., Australia, Canada, Europe and Latin America, Covidien said.
Covidien Customer Service can be reached at 1.800.716.6700 from 7 a.m. to 7 p.m. Central Time or by email at [email protected].
To submit a report to the FDA about adverse reactions or quality problems with these devices, go to www.fda.gov/medwatch/report.htm.