Abbott Medical has recalled its Dragonfly OpStar Imaging Catheter because potential loose catheter marker bands in the device may cause harm to patients.
Five incidents and one injury related to the device have been reported because the marker band farthest from the catheter tip (proximal marker) may become loose and separate from the catheter while being used during a procedure. No deaths have been reported.
Abbott issued an urgent recall letter to all customers who received affected devices on April 11, with 4,800 devices recalled in the U.S. The U.S. Food and Drug Administration has classified the issue as class 1 in its recall notice.
Abbott said loose marker bands that separate from the device may remain in the body after the catheter is removed, potentially leading to vascular injuries, including but not limited to embolism (blockage of the vessel), thrombosis (blood clot), dissection (tear), ischemia (inadequate blood supply to the heart), infarction (heart attack), infection, or death.
Customers with questions or concerns should contact their local Abbott representative or call the customer service department at 800-227-9902, the company said.