Beacon Tip Angiographic Catheter Products have been found to exhibit tip splitting or separation which has resulted in severe outcomes for patients. Device maker Cook Medical has received complaints of catheter-tip splitting and/or separation and issued a voluntary product recall.
This medical device product recall of angiographic catheters represents a serious and potentially fatal health situation for patients with the catheter. A catheter that splits or separates could enter the patient’s bloodstream and block blood flow to other organs and parts of the body. Medical intervention would be required to retrieve a split or separated catheter section.
The U.S. Food and Drug Administration (FDA) has been notified of this action.
This Class 1 recall is the most serious type of recall because they involve situations in which there is a “reasonable probability” that using the products “will cause serious adverse health consequences or death,” according to the FDA’s explanation recall classifications. Medical device safety alerts are issued by the FDA to let the public known that a medical device “may present an unreasonable risk of substantial harm.”
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Allen & Allen is currently investigating cases on behalf of injured users. If you or one of your loved ones is using a Beacon Tip Angiographic Catheter Product, contact the attorneys at Allen & Allen online or by calling 1-866-388-1307.
Details on Beacon Tip Angiographic Catheter Products
The catheter injects contrast dye into blood vessels in the heart to prepare it for an X-ray used in cardiac angiograms. Patients with Cook Medical’s Beacon Tip Angiographic Catheters received them during medical procedures to diagnose heart conditions. A small puncture is made in the skin and the catheter is inserted into the body through the puncture and placed into the blood vessel along a guide wire.
Cook Medical’s product recall includes specific versions and lot numbers of the Torcon NB® Advantage Beacon® Tip Catheters (Catalog Prefix HNBR5.0), Royal Flush® Plus Beacon® Tip High-Flow Catheters (Catalog Prefix HNR4.0), and Slip-Cath® Beacon® Tip Catheters (Catalog Prefix SCBR5.0).
About The Author: Jason Konvicka is a partner and trial attorney with Allen & Allen in Richmond, Virginia. During his 20+ year career, he has achieved numerous record-setting jury verdicts and substantial settlements on behalf of his clients. His practice focuses on medical malpractice, bus accidents and product liability personal injury cases. Outside of the courtroom, Jason is involved with the Virginia Trial Lawyers Association and currently serves on its Board of Governors as Vice President.