September 21, 2021

FDA: Class I recall of Medtronic Pipeline Flex Embolization devices

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA), on September 20, identified Medtronic’s recall of its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology as Class I, the most serious.

The devices, which are used to treat brain aneurysms, were recalled because there is a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is being used to place, retrieve, or move the stent inside a patient.

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Distribution dates were April 18, 2019 to August 13, 2020.

To date, there have been 59 reported device malfunctions, 10 serious injuries, and 2 deaths related to this recall.


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