|Covidien's Pipeline Embolization Device--Courtesy of Covidien|
The FDA slapped its most severe category on Covidien's ($COV) now-Class I recall of certain lots of its Pipeline Embolization Device and Alligator Retrieval Device, meaning "there is a reasonable probability that use of these products will cause serious adverse health consequences or death," in the agency's words.
Covidien initiated the recall of the devices on April 1 due to concerns about the coating on their delivery wires, which could delaminate and detach from the device. Its Class I status gives the recall greater urgency. Particulate from the detached polytetrafluoroethylene coating could cause a blockage in the blood vessels of the brain, leading to stroke or even death, Covidien and the FDA say.
The FDA's notice urged customers to stop using the recalled devices and separate them from other inventory. The notice contains the lot numbers of the recalled devices as well as the address to which the faulty devices should be sent. Covidien will then mail replacements to the affected customers.
The FDA says Covidien reported one instance of delamination, but it did not result in death or injury. Covidien said it decided to initiate the recall after conducting internal tests on the products.
Overall, 621 of the Alligator devices, for foreign body removal in the peripheral and neurovasculature, and 32 Pipeline Embolization Devices, for the treatment of adults with intracranial aneurysms in the internal carotid artery, are subject to the recall.
- here's the FDA notice about the recall
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