The FDA today issued a notice confirming a Class I recall of the Pipeline Flex embolization device from Medtronic (NYSE:MDT).
Several models of the Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology were affected, with 8,825 devices recalled in the U.S., having been distributed between April 18, 2019, and Aug. 13, 2020.
According to an FDA release, Medtronic initiated the recall on July 13, 2021. There have been 59 reported device malfunctions, 10 serious injuries and two deaths related to the recall.
The company recalled the devices due to a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is in use to place, retrieve or move the stent inside a patient. Fractured pieces could stay inside the patient’s brain bloodstream, while there is the possibility that attempts to retrieve the fractured pieces may worsen the patient’s condition. The fragments can als…