Medtronic Recalls Pipeline Flex Embolization Devices

Medtronic is recalling the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology 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.

Fractured pieces could be left inside the patient’s brain bloodstream. It is also possible that attempts to retrieve the fractured pieces may make the patient’s condition worse. The fragments can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death.

There have been 59 reported device malfunctions, 10 serious injuries, and two deaths related to this recall. The FDA has identified this as a Class I recall, the most serious type of recall.

Models numbers affected include:

Pipeline Flex Embolization Device: PED-250-XX, PED-275-XX, PED-300-XX, PED-325-XX, PED-350-XX, PED-375-XX, PED-400-XX, PED-425-XX, PED-450-XX,PED-475-XX, PED-500-XX

Pipeline Flex Embolization Device with Shield Technology: PED2-250-XX, PED2-275-XX, PED2-300-XX, PED2-325-XX, PED2-350-XX, PED2-375-XX, PED2-400-XX, PED2-425-XX, PED2-450-XX, PED2-475-XX, PED2-500-XX

The Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology are permanent mesh cylinders (stent) braided from platinum and tungsten and cobalt-chromium-nickel alloy wires. These devices are intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel (wide-neck and fusiform). The Pipeline Flex Devices include a guidewire-based delivery system used to place the implant inside the patient.

Healthcare providers should stop use of any impacted product. All unused impacted products should be immediately quarantined. Return impacted products to Medtronic.

Contact your Medtronic representative for help with product returns or to identify a suitable replacement product if one is needed.

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