Cook Medical Beacon Tip Angiographic Catheter Recall Lawsuit
Beacon Tip Angiographic Catheter Recall Lawsuit Investigation After Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters and Slip-Cath Beacon Tip Catheters Have Potential Risk of The Catheter Tip Splitting or Separating From The Catheter
Recent Reports have resulted in a voluntary Cook Medical Beacon Tip Angiographic Catheter Recall. The Class 1 recall of 2,239 lots of Beacon Tip Angiographic Catheters are due to the potential risk of the catheter tip splitting or separating from the catheter. The medical device recall covers 95,167 angiographic catheters worldwide, which includes 38,895 in the United States, according to Cook Medical’s July 2 news release posted on the U.S. Food and Drug Administration’s (FDA) website. Cook Medical, based in Bloomington, Indiana, has received 26 reporting of the device malfunctioning, with 14 complaints of the tip either splitting or separating. Tip splitting or separation can cause the catheter to stop working, the company said. After separating from the angiographic catheter, the tip could enter a patient’s bloodstream and cause serious injury requiring additional medical intervention to recover the tip, and may also cause death. The splitting or separation could block blood flow to end organs, Cook Medical stated in its news release.
[fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm, July 2, 2015]
Southern Med Law is currently investigating Beacon Tip Angiographic Catheter recall Lawsuit claims. If you or a loved one have been seriously injured by Beacon tip splitting or Beacon tip separation or if your loved one died as a result of the medical device’s malfunction, please contact the medical device litigation attorneys at Southern Med Law for a free evaluation of your claim. To speak with one of our lawyers, please call 205-547-5525 or visit www.southernmedlaw.com and fill out the form on our website.
Beacon Tip Angiographic Catheters
The Beacon Tip Angiographic Catheters are intended to be used in angiographic procedures by physicians trained and experienced in angiographic techniques, according to Cook Medical, which manufactures medical devices including surgical transvaginal mesh and IVC filters that are designed to stop blood clots from reaching a patient’s lungs. The angiographic catheters are used to inject contrast dye into blood vessels in the heart to prepare it for 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.
[fda.gov/Safety/Recalls/ucm457068.htm, August 3, 2015]
Beacon Tip Angiographic Catheters Recall Models
Cook Medical’s Class 1 recall is the most serious recall classification because it involves “situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death,” according to the FDA’s explanation of recall classifications. Cook Medical’s July 2 letter directed its customers to immediately quarantine the following unused angiographic catheters from their inventory and collect and return them to the company as soon as possible:
• Beacon Tip Torcon NB Advantage Catheters – Catalog Prefix HNBR5.0
• Beacon Tip Royal Flush Plus High-Flow Catheters – Catalog Prefix HNR4.0
• Slip-Cath Beacon Tip Catheters – Catalog Prefix SCBR5.0
The Beacon Tip Angiographic Catheters involved in the recall were manufactured between May 9, 2013, to September 1, 2014, and distributed between June 2013 and June 2015. Products can be identified by the part numbers and lot number on the outside package product label. The complete list of lot numbers are available on the FDA’s and Cook Medical’s websites. This is not the first time Cook Medical has recalled its medical devices. According to the FDA, Cook Medical issued a medical device recall in 2013 of its Zilver PTX Drug-Eluting Peripheral Stent, a self-expanding, small metal, mesh tube with the outer surface coated with the drug Paclitaxel that is implanted in an artery of the thigh. The Paclitaxel coating helps prevents the artery from narrowing again. Cook Medical received reports that the delivery system of the device had separated at the tip of inner catheter. In these instances, surgery may be needed to remove the catheter tip, vascular occlusion due to an unretrieved catheter tip, thrombosis, amputation, possible cardiac arrest, and death, according to Cook Medical’s news release.
[fda.gov/MedicalDevices/Safety/ucm353868.htm, April 18, 2013]
Beacon Tip Angiographic Catheters Legal Evaluations
If you have experienced a catheter-tip splitting and/or catheter-tip separation that seriously affected your health or if your loved one died due to an angiographic catheter malfunction, you may be eligible to receive compensation from Cook Medical. Southern Med Law aggressively fights for victims of defective medical devices to get them the help and results they deserve.
About Southern Med Law and Filing A Beacon Tip Angiographic Catheter Recall Lawsuit
Southern Med Law Is a Full Service Law Firm Providing Legal Representation To Men and Women across the country in lawsuits who were victims of negligent personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
Southern Med Law
François M. Blaudeau, MD JD FACHE FCLM Esquire
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Birmingham, Alabama 35203
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