The U.S. Food and Drug Administration (FDA) has identified Abbott’s recall of its Dragonfly OpStar Imaging Catheter as a Class I recall, the most serious type. Abbott issued the recall on April 11 because the marker band farthest from the catheter tip, proximal marker,) may become loose and, in two instances, has been observed to separate from the catheter while being used on a person, according to an FDA advisory posted Thursday. A loose marker band that has separated from the device may remain in the body after the catheter is removed, potentially leading to vascular injuries, including embolism, thrombosis, dissection, ischemia, infarction, infection or death, according to the advisory. There have been five incidents, one injury and no deaths reported to be related to this device issue. Abbott directed physicians to stop using the catheter and return any unused devices. Healthcare professionals and consumers may report adverse reactions or quality issues to the FDA’s MedWatch program. Image Credit: iQoncept - stock.adobe.com