Philips‘s Image Guided Therapy Services division has sent out an urgent medical device recall letter for its Tack Endovascular System, according to a March 3 announcement from the U.S. Food and Drug Administration (FDA).
The FDA is classifying this recall as the “most serious type,” noting that the device can “cause serious injury or death.” The recall involves removing Tack Endovascular System from where it is used or sold and covers three versions (4F, 1.5 mm to 4.5mm, 150cm; 6F, 3.5 mm to 6 mm, 135cm; and 6F, 4 mm to 8 mm, 135cm).
Philips is recalling Tack Endovascular Systems “due to challenges experienced by customers during use, including events where additional interventions were required to retrieve or remove the Tack implant,” the FDA said. “All customers should stop using the Tack Endovascular System immediately. Philips will no longer distribute this system for use.” Possible adverse health effects include “partial or completely blocked blood flow … holes or tears in the inner lining of the artery … through the entire artery wall … [and] long-term risks such as pain, tissue loss, re-narrowing of a widened or stented vessel, the need for bypass surgery, amputation, and death,” according to the FDA’s statement.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program, the FDA said.