The U.S. Food and Drug Administration (FDA) initiated a Class 1 recall for a select group of Medtronic Pipeline Flex Embolization products. The FDA Pipeline recall was initiated after the organization discovered that the stents could fracture during or after placement.
As described in the FDA Pipeline recall announcement, Medtronic’s Pipeline Flex embolization device is “a permanent mesh cylinder (stent) braided from platinum and tungsten and cobalt-chromium-nickel alloy wires intended for the treatment of brain aneurysms that bulge or balloon out the sides of the blood vessel.” Ordinarily, this mesh would restrict blood flow to the ballooning aneurysm, shrinking it over the course of a couple months and reducing the likelihood of a life-threatening rupture.
As the FDA Pipeline recall demonstrates, these products contain a dangerous defect. During the surgical implantation of the Medtronic device in aneurysm patients, “Fractured pieces of the delivery system could be left inside the patient's brain bloodstream,” according to the FDA. Additionally, they explain that these pieces or the attempts to retrieve them can exacerbate issues the device was made to prevent.
Ultimately, these faulty devices could lead to failure in preventing blood vessel blockage, strokes and even death.
The FDA Pipeline recall affects 822 devices manufactured and distributed by Medtronic from Oct. 22, 2019, to Feb. 7, 2020. According to the FDA Pipeline recall announcement, the following device types have been recalled:
Pipeline Flex Embolization Devices:
- PED-350 -XX
Pipeline Flex Embolization Devices with Shield Technology:
- PED2 -275-XX
- PED2 -425-XX
- PED2 -450-XX
The FDA and Medtronic are calling on suppliers to take inventory. If any of the products subject to the FDA Pipeline recall are discovered, they should be pulled from active inventory and returned to Medtronic where they can be properly disposed of. It is vital for the safety of patients that these faulty devices be removed from the stream of commerce as quickly as possible.
Patients who may soon be receiving a Medtronic Pipeline Flex Embolization device should talk to a physician about whether the device used is one affected by the FDA Pipeline recall.