Class 1 Recall for Medtronic's Flex Embolization Devices

Megan Brooks

March 30, 2020

Medtronic is recalling the Pipeline Flex embolization device and Pipeline Flex embolization device with shield technology because the system used to deliver the stent could fracture during placement.

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

"Fractured pieces of the delivery system could be left inside the patient's brain bloodstream, and this, or the attempts made to retrieve the fractured pieces, can make the patient's condition worse. This can also cause other serious adverse health consequences such as continued blockage of blood vessels, stroke, and death," the US Food and Drug Administration (FDA) says in a recall notice.

The agency has received 50 medical device reports, with 10 injuries and 1 death, between November 1, 2019 and March 1 of this year.

The FDA says there is no increased risk to patients for Pipeline Flex stents that have already been placed successfully.

The recall involves 822 devices in the US, made between October 22, 2019 and February 1, 2020 and distributed between November 6, 2019 and February 7, 2020. Product codes are listed in the FDA recall notice.

In an urgent medical device recall notice, Medtronic asks customers to 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 763-514-4000 (worldwide), 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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