FDA MedWatch - Pipeline Flex Embolization Devices by Medtronic:

Class I Recall - Due to Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC: Pipeline Flex Embolization Devices by Medtronic: Class I Recall - Due to Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device AUDIENCE: Patient, Health Professional, Risk Manager, Neurology ISSUE: 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. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: 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).  RECOMMENDATIONS: On July 13, 2021, Medtronic sent an urgent medical device recall letter to customers requesting them to:  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.  Complete and return the customer response form via fax to Medtronic. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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