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Medtronic (Micro Therapeutics, Inc. d/b/a ev3 Neurovascular) Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device

Medtronic (Micro Therapeutics Inc. d/b/a ev3 Neurovascular) is recalling the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because of the 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.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Questions?

Customers can contact the recalling firm’s Quality Assurance via email at rs.nvcomplaints@medtronic.com or by calling 1(800) 633-8766 (U.S. toll free).