FDA: Class I Recall for Medtronic’s Pipeline Flex and Pipeline Flex With Shield Technology

Medtronic is recalling two of its products—the Pipeline Flex and the Pipeline Flex with Shield Technology, both embolization devices for the treatment of intracranial aneurysm—due to reports that their guidewire-based delivery system might fracture during stent implantation. The US Food and Drug Administration has deemed it a Class I recall, the most serious type.

“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 FDA warned yesterday in its announcement.

However, the agency said, there is no risk to patients whose permanent flow-diverting stents have already been implanted.

Between November 1, 2019, and March 1, 2020, the FDA received 50 reports regarding the issue; these include 10 injuries and one death.

Medtronic sent out an Urgent Medical Device Recall Notice on February 24, 2020, to healthcare professionals, urging them to not use affected products and to return them to the company. The list of affected product codes can be found in the FDA’s announcement.

Adverse reactions or quality problems with the devices can be sent to the agency’s MedWatch reporting program.