Medtronic PLC just recalled certain lots of four of its neurovascular products. The device maker noted that the recalled devices might lead to a thromboembolic event (blood clot) in patients. The recalled Medtronic neurovascular products are:
- Pipeline Embolization Device (1742 lots affected)
- Alligator Retrieval Device (171 lots affected)
- X-Celerator Hydrophilic Guidewire (210 lots affected)
- UltraFlow HPC Flow Directed Micro Catheters/Marathon Flow-Directed Micro Catheters (1790 lots affected)
Medtronic indicated that the polytetrafluoroethylene (PTFE) coating that covers areas of the devices might potentially separate from the delivery wire or stylets, entering a patient’s blood stream. This may lead to a blood clot, noted The Wall Street Journal. According to Medtronic, it began issuing recall letters on October 5 and is asking customers to quarantine all of these recalled products and to return the products to Medtronic. The U.S. Food and Drug Administration (FDA) and other regulatory bodies have been notified, according to Medtronic.
The FDA issued a release of Medtronic’s announcement of the recall of the Medtronic Neurovascular business products. The business is part of the Brain Therapies division in the Medtronic’s Restorative Therapies Group, the FDA pointed out. When the recall was implemented, 84,278 units were potentially affected. The products were distributed worldwide and were manufactured from July 2014 to September 2016. A list of specific lot numbers may be accessed here.
According to the FDA, the Pipeline™ embolization device, which was approved in 2011, is indicated for the “endovascular treatment of adults” (individuals who are 22 years of age and older) diagnosed with “large or giant wide-necked intracranial aneurysms” located in the “internal carotid artery from the petrous to the superior hypophyseal segments.” In other words, the Pipeline device redirects blood away from an embolism. The first generation Pipeline™ embolization device is affected by the recall. The PTFE coated delivery wire is part of the disposable delivery system; the braid implant is not affected and the second-generation device—the Pipeline™ Flex embolization device—is not affected.
The Alligator™ retrieval device was created for use in the “peripheral and neuro-vasculature” to retrieve foreign bodies and the X-Celerator™ hydrophilic guidewire is meant for “general intravascular” use to help in “the selective placement of catheters in the peripheral, visceral, and cerebral vasculature during diagnostic and/or therapeutic procedures,” the FDA explained. The UltraFlow™ flow directed micro catheter is meant for the “subselective infusion of physician-specified therapeutic agents,” including “embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels.” The Marathon™ Flow Directed Micro Catheter is meant to access “peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents,” including “embolization materials and of diagnostic materials such as contrast,” according to the FDA.
Some lots of the Pipeline and Alligator devices were recalled in 2014 after reports were received concerning delamination and detachment of the PTFE coating, which is meant to minimize device-guidewire friction. The FDA cleared the Pipeline in late 2014; however, the same problem has reemerged and the most recent recall has been expanded.