FDA Issues Update on Medtronic’s Recall of Embolization Devices
The FDA issued on update on Medtronic’s July 13 recall of certain models of its Pipeline Flex embolization devices, deeming it a Class I recall because of the risk of serious injury or death.
The devices are mesh stents braided from platinum and tungsten and cobalt-chromium-nickel alloy wires, intended to treat brain aneurysms that bulge out of blood vessels. The Pipeline Flex devices include a guidewire-based delivery system used to place the implant inside the patient.
The reason for the recall is a risk of the delivery system’s wire and tubes fracturing and breaking when the system is being used to place, retrieve or move the stent inside a patient. There have been 59 reported malfunctions, 10 serious injuries and two deaths related to the recall, the FDA said.