FDA Issues Update on Medtronic’s Recall of Embolization Devices

September 22, 2021

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.

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