The tip could enter the patient’s bloodstream, causing serious injury or even death. Device maker Cook Medical has recalled nearly 39,000 Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters because of reports that the catheter tip may split or separate from the catheter.
If the tip does split or separate, there can be serious health consequences. The tip could enter the patient’s bloodstream, causing serious injury or even death, and additional intervention could be needed to retrieve the tip. According to the recall notice, tip splitting or separation may also cause the device to stop working, interfering with the imaging procedure. The recall notice with the complete list of affected lot numbers can be found on the Food and Drug Administration (FDA) web site.
Beacon Tip Angiographic Catheters are used in a cardiac angiogram to inject contrast dye into blood vessels in the heart to prepare it for imaging. Cardiac angiogram is a type of X-ray that is used to diagnose and sometimes treat heart conditions. The catheter is inserted into the body through a small puncture made in the skin and placed into the blood vessel along a guide wire before injecting the contrast dye.
During a coronary angiogram, the X-ray machine takes a series of images (angiograms) that offer a detailed look the heart’s blood vessels. If necessary, the doctor can perform procedures such as an angioplasty during the angiogram, the Mayo Clinic explains. Major complications are rare, but there is the risk of heart attack, stroke, injury to the artery, allergic reaction to the dye or medications, excessive bleeding, and infection, according to the Mayo Clinic.
Cook Medical says it has received 26 reports of malfunctioning devices
Cook Medical says it has received 26 reports of the device malfunctioning. Fourteen of these malfunctions resulted in reported adverse events. The FDA has classified this a Class 1 recall, the agency’s most serious device recall category. In a Class 1 recall, there is a reasonable probability that use of the products will cause serious adverse health consequences or death.
The recalled catheters, manufactured from May 9, 2013 to September 1, 2014, were distributed from June 6, 2013 to June 25, 2015, according to the FDA. The recall includes 38,895 catheters in the United States.
Cook Medical sent an Urgent Medical Device Recall letter to customers on July 2, advising them to immediately quarantine the recalled catheters and return them to Cook Medical. Customers can contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235, Monday through Friday from 7:30 a.m. to 5:00 p.m., EST.
Cook Medical asks customers to report any adverse events to the company at 800-457-4500 or 812-339-2235, Monday through Friday from 7:30 a.m. to 5:00 p.m., Eastern Time or to CustomerRelationsNA@cookmedical.com. The FDA also encourages health care professionals and patients to report adverse events or side effects through the MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/medwatch/report.htm.