Medtronic Recalls Pipeline Flex Embolization Device

Medtronic has recalled (Class 1) its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the delivery system could fracture while placing the stent inside a patient. “Fractured pieces of the delivery system could be left inside the patient’s brain bloodstream, and this or the attempts made to retrieve the fractured pieces, can make the patient’s condition worse,” a recall notice says. “This can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death.” FDA has received 50 medical device reports that listed 10 injuries and one death. The permanent mesh cylinder stent braided from platinum and tungsten and cobalt-chromium-nickel alloy wires is intended for treating brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform).