Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device
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.
- Product Names: Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
- Models Numbers:
- 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
- Full Product Codes: See Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology Recall Database Entries
- Devices Recalled in the United States: 8,825 (Limited only to the Pipeline Flex Embolization Device)
- Distribution Date: April 18, 2019 to August 13, 2020
- Date Initiated by Firm: July 13, 2021
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.
Reason for Recall
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 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. In the United States (U.S.), the recall is only limited to the Pipeline Flex Embolization Device. Outside the U.S., the recall applies to both the Pipeline Flex Embolization Device and the Pipeline Flex Embolization Device with Shield Technology.
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.
Who May Be Affected
- Health care providers using the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
- Patients who require care using the Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology
What to Do
On July 13, 2021, Medtronic, the parent company of Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, 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 at 1-651- 367-7075, Attention: Neurovascular Quality or email it to firstname.lastname@example.org.
Customers with questions about this recall can contact the recalling Medtronic’s Quality Assurance via email at email@example.com or by calling 1(800) 633-8766 (U.S. toll free).
- Pipeline Flex Medical Device Recall Database Entry
- Pipeline Flex with Shield Technology Medical Device Recall Database Entry
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.