FDA Class I Recall for Medtronic's Flex Embolization Devices

Megan Brooks

September 20, 2021

Medtronic is recalling the Pipeline Flex embolization device and Pipeline Flex embolization device with shield technology because the delivery system's wire and tubes could fracture and break off when the system is being used to place, retrieve, or move the stent.

The Pipeline Flex embolization device is a braided cylindrical permanent mesh stent used to treat certain intracranial aneurysms. A guide wire-based delivery system is used to place the stent.

The recall notice posted on the US Food and Drug Administration (FDA) website cautions that "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," the notice warns.

The FDA has identified this as a Class I recall, the most serious type due to the potential for serious injuries or death.

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

The recall involves 8825 devices in the US, distributed between April 18, 2019 and August 13, 2020. A link to product codes are listed in the FDA recall notice.

The models being recalled are the following:

  • 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

It's not the first time Medtronic has recalled Pipeline Flex embolization devices. In March 2020, the company recalled 822 devices in the US for the same problem, as reported by Medscape Medical News

In an urgent medical device recall notice, Medtronic asks customers not use any affected product and remove and quarantine all unused affected products in inventory.

Affected products should be returned to Medtronic. Customers with questions may contact Medtronic Quality Assurance by phone at 1-800-633-8766 (US toll free), or by email at rs.nvcomplaints@medtronic.com

Adverse reactions or quality problems related to this recall should be reported to the FDA's MedWatch program.


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