Medtronic recalled a brain aneurysm stent device Sept. 20 because of a risk of malfunction that has been linked to 10 serious injuries and two deaths.
The company recalled its Pipeline Flex embolization device, a permanent mesh stent, because of a risk of the wire and tubes on the device's delivery system to fracture and break off when the stent is being placed, retrieved or moved inside the patient.
The Pipeline Flex embolization device is used to treat brain aneurysms that bulge or balloon out of the sides of a blood vessel.
Fractured pieces of the stent could be left inside a patient's brain bloodstream. It's also possible that attempts to retrieve fractured pieces could make a patient's condition worse, and fragments could cause continued blockage of blood vessels, stroke or death, the FDA said.
Medtronic has received 59 reports of device malfunctions, 10 reports of serious injuries and two reports of death related to the recall.
Read the FDA's full news release here.