According to the American Heart Association, a coronary angiogram is an X-Ray test which is used to find out if a person’s coronary arteries are blocked or narrowed, and if so, by how much. Arteries can often be blocked by cholesterol, cells, or other substances commonly referred to as “plaque.” If there is too much blockage, or a blood clot forms and blocks the flow, a heart attack can transpire.
In order to conduct the X-Ray and view the results, a special dye is injected, which circulates through the arteries, allowing the medical team to view the results. From there, the doctor will determine if coronary artery bypass surgery is required, also known as a “coronary artery bypass graft,” or simply, CABG.
To conduct the X-Ray, the dye is inserted through a catheter, which is a long sterile tube. An example of the recalled Torcon NB® Advantage Beacon® Tip Catheter is pictured below.
The Cook Medical Beacon Tip angiographic catheters at the center of the investigation have been reported to either split or break at the tip while inside the patient’s vasculature. This can lead to the device traveling throughout the body, and becoming lodged in an organ or vein.
The Beacon Tip catheters subject to the recall were on the market from June 2013 to June 2015, with approximately 38,800 sold domestically. Figuring how many of these tests have been done per day, the number of affected individuals who may have suffered a serious injury, such as an organ or blood vessel puncture, could be in the thousands.
What is a Class I Recall? What Models are Affected?
A Class I FDA recall is the most serious type of recall, and only given to products which may result in injury or death.
To date, the recall of the Cook Medical catheters includes all lots, including the following list of products:
- Beacon® Tip Torcon NB® Advantage Catheter
- Beacon® Tip Royal Flush® Plus High-Flow Catheter
- Beacon® Tip Centimeter Sizing Catheter
Beacon® Tip White Vessel Sizing Catheter
Beacon® Tip Vessel Sizing Catheter
- Shuttle® Select Slip-Cath
- Slip-Cath® Beacon® Tip Catheter
- FluoroSet® Radiographic Tubal Assessment Set
- Haskal Transjugular Intrahepatic Portal Access Set
- Kumpe Access Catheter
- Liver Access and Biopsy Needle Set
- Neff D’Agostino Percutaneous Access Set
- Aprima™ Access Nonvascular Introducer Set
- Selective Salpingography Catheter with Beacon® Tip
- Transluminal Biliary Biopsy Forceps Set
- White Lumax® Guiding Coaxial Catheter
Who’s to Blame?
It’s important to realize that this is most likely not your physician’s fault. Using a catheter for an angiogram is common and occurs daily. Our firm is investigating claims strictly against the manufacturers of catheters, which have been recalled due to breakage. Other catheter manufacturers we are investigating in addition to Cook Medical include C. R. Bard, as well as a subsidiary of Stryker.
In June 2016, Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) recalled its Flush Angiographic catheter due to the same issue as the Cook catheter: tip separation. The product was on the market from January 2005 – December 2008, and included more than 167 devices recalled in Texas, Utah, Pennsylvania, California, Vermont, Maine, Washington, Virginia, New York, Maryland, and Connecticut.
If you or someone you know had an angiogram conducted and suffered complications, a defective catheter made by Bard, Cook, or Stryker may have been used. Due to time limits when filing claims, we recommend you contact us as soon as possible. Our law firm has helped individuals around the U.S. in defective medical device cases, and we can assist you, too. Let us handle all of the legal aspects, such as collecting medical records and handling the time-consuming paperwork. Our firm works on a contingency-fee, so there are no upfront costs, fees, or expenses, unless we are able to recover on your behalf.
If you have any questions, start by having a confidential conversation with one of our attorneys. We can be reached at 866-515-8880. The call is free, and there is no obligation to pursue a claim. Contact us today to learn your legal rights.