The FDA today issued a notice confirming a Class I recall of the Pipeline Flex embolization device from Medtronic (NYSE:MDT).
Several models of the Pipeline Flex embolization device and Pipeline Flex embolization device with Shield Technology were affected, with 8,825 devices recalled in the U.S., having been distributed between April 18, 2019, and Aug. 13, 2020.
According to an FDA release, Medtronic initiated the recall on July 13, 2021. There have been 59 reported device malfunctions, 10 serious injuries and two deaths related to the recall.
The company recalled the devices due to a risk of the delivery system’s wire and tubes fracturing and breaking off when the system is in use to place, retrieve or move the stent inside a patient. Fractured pieces could stay inside the patient’s brain bloodstream, while there is the possibility that attempts to retrieve the fractured pieces may worsen the patient’s condition. The fragments can also cause other serious adverse health consequences, including continued blockage of blood vessels, stroke and death.
In March 2020, Medtronic had another Class I recall for Pipeline Flex also related to device fracture. Although that recall did not affect Pipeline Flex devices with Shield Technology, the company recalled 822 total devices in the U.S., reporting 50 medical device reports with 10 related injuries and one related death.
Medtronic designed the Pipeline Flex device for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms from the petrous to the superior hypophyseal segments. In February 2019, it won expanded FDA indication for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery.
In April of this year, Medtronic received FDA approval for the Pipeline Flex embolization device with Shield Technology for advancing flow diversion therapy through a surface-modified implant device that demonstrates a reduction in material thrombogenicity — a reduction in the tendency of the surface treatment material to create clots.
With the latest recall, Medtronic instructed customers to stop the use of any impacted product, with all unused impacted products to be quarantined immediately. Those products should eventually be returned to Medtronic and customers should contact a Medtronic representative for help with product returns or to identify a suitable replacement product if one is needed.
Medtronic did not immediately respond to a request for comment. This story may be updated.