FDA Class 1 Recall Announced for Cook Medical Beacon Tip Catheters

The recall of nearly 39,000 Cook Medical Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters whose tips may split or separate from the catheter has been designated a Class 1 recall.

The Food and Drug Administration (FDA) reserves the Class 1 recall designation—its most serious—for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death.

If the tip does separate, it 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. Cook Medical says it has received 26 reports of the device malfunctioning. Fourteen of these malfunctions resulted in reports of adverse events.

Beacon Tip Angiographic Catheters are used in a cardiac angiogram to inject contrast dye into blood vessels in the heart. to prepare it for a cardiac angiogram, a type of X-ray used to diagnose heart conditions (cardiac angiogram). 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 provide a detailed look at the heart’s blood vessels. If necessary, the doctor can also perform procedures such as an angioplasty during the coronary angiogram, the Mayo Clinic explains. While major complications are rare, the Mayo Clinic says there is a risk of heart attack, stroke, injury to the artery, allergic reaction to the dye or medications, excessive bleeding, and infection.

The recalled catheters were manufactured between May 9, 2013 and September 1, 2014, and were distributed from June 6, 2013 to June 25, 2015, according to the FDA. The recall included 38,895 catheters in the United States. The recall notice with the complete list of affected lot numbers can be found on the Food and Drug Administration (FDA) web site.

Cook Medical sent out an Urgent Medical Device Recall letter on July 2, instructing customers to immediately quarantine the recalled catheters and return them to Cook Medical as soon as possible. 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 related to the use of these catheters through the MedWatch Safety Information and Adverse Event Reporting Program: www.fda.gov/medwatch/report.htm.

 

 

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