Medtronic Pipeline Flex Embolization Recall Follows Reports of Serious Injuries, Deaths

Nearly 9,000 Medtronic Pipeline Flex Embolization devices used to treat brain aneurysms have been recalled, following reports of serious injuries and at least two deaths which may have been caused by broken pieces of the device entered patients’ brains.

The FDA announced the Medtronic Pipeline Flex Embolization Device recall on September 20, following reports of wires and tubes fracturing and breaking off, sometimes within patients’ bodies. According to the agency, there have been 59 reports of device malfunctions, resulting in 10 serious injuries and two deaths.

The recalled embolization devices are mesh cylinder stents made of platinum, tungsten, and cobalt-chromium-nickel alloy wires. They are used to treat brain aneurysms which bulge out of the side of blood vessels. They are put in place with a guidewire delivery system.

However, according to the recall notice, there is a risk of the delivery system’s wires and tubes fracturing and breaking while the delivery system is putting the stent into place or while removing it or moving it to a new location. This could result in pieces entering the patient’s bloodstream, blocking blood vessels, or causing strokes and death. In addition, removing the pieces can also worsen the patient’s condition.

Medtronic initiated the recall on July 13 and sent an urgent medical device recall letter to its customers. However, this week the FDA declared the letter a Class I recall, the most serious classification, meaning the FDA believes the problem can cause severe injuries or deaths.

The recall affects the Medtronic Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology. Affected model numbers 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

An estimated 8,825 devices were distributed in the U.S. between April 18, 2019 and August 13, 2020.

The Medtronic recall letter requested customers stop using the product immediately and quarantine the products from use. Customers should also return unused products to Medtronic.
Questions or problems concerning the recall can be directed to Medtronic’s Quality Assurance at 800-633-8766 or by emailing rs.nvcomplaints@medtronic.com.

Side effects can be reported to the FDA’s MedWatch Adverse Event Reporting Program.