Note: This article was updated Tuesday, Jan. 25, to reflect new information received from Medtronic. The U.S. Food and Drug Administration (FDA) announced a Class I recall Friday of Medtronic’s HawkOne Directional Atherectomy System because of the risk that the catheter tip could break off and potentially tear or rupture an artery. A class I recall is the most serious type, meaning that the affected product poses a threat of serious injury or death. According to the FDA’s recall notice, Medtronic initiated the recall because of the risk that the guidewire within the catheter could move downward or prolapse when force is applied during use. If this happens, the notice says, catheter tip could break off or separate, which could lead to serious adverse events such as a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (ischemia), or blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached or migrated (embolized) tip. To date, there have been 163 complaints about this device issue, with 55 injuries and no deaths reported, the FDA said. In a statement, Medtronic noted that its letter to customers reported that the rate of reported tip damage was 0.168%. In most instances, the issue was resolved without affecting patients, but a small number required endovascular retrieval (0.033%) or open surgical retrieval (0.028%). Medtronic's statement added that no product retrievals or disposes are associated in association with the recall, nor are any actions required for patients treated with the device. "Physicians should continue to monitor patients in accordance with their medical facility's standard care protocols," the statement says. Anyone with questions about this recall should contact the Medtronic field representative or call Medtronic Customer Service at (800) 854-3570. Image Credit: Michail Petrov – stock.adobe.com