Cook Medical Says Its Beacon Tip Angiographic Catheter Tip Can Potentially Slipt or Separate Causing Serious Injury Or Death
Cook Medical has expanded its Beacon Tip Angiographic Catheter recall globally. Cook voluntary issued the catheter recall after 42 reports of the catheter tip either splitting or separating. The separation of the catheter tip can potentially stop the device from working and may cause death or serious injury if the tip enters the bloodstream. Removal of the catheter would require medical intervention to retrieve a separated segment or may block blood flow to end organs, Cook Medical explained. The malfunction places patients in jeopardy because the splitting and separating can cause the catheter to stop working, according to the company.
The Class 1 recall includes specific versions of the:
- Torcon NB Advantage Beacon Tip Catheters – Catalog prefix HNBR4.0, HNBR4.1 and only HNBR5.0 with the RUC suffix
- Royal Flush Plus Beacon Tip High-Flow Catheters – Catalog Prefix HNR4.0
- Slip-Cath Beacon Tip Hydrophilic Catheters – Catalog prefix SCBR4.0, SCBR4.1, and only SCBR5.0 with the RUC suffix
- Shuttle Select Slip-Cath catheters – Catalog Prefix SCBR4.5
All of the recalled catheters were distributed globally between September 2012 and September 2015, and all lots currently in distribution are affected, according to the company. Cook Medical sent recall notification letters to all of its customers and distributors, and to the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world.
[fda.gov/Safety/Recalls/ucm466545.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery, October 9, 2015]
“According to the FDA’s explanation of recall classifications, a Class 1 recall is the most serious because it involves situations in which there is reasonable probability that using the recalled products will cause serious adverse health consequences or death.” – Southern Med Law
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.
Cook Medical’s Angiographic Beacon Tip Catheters: 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. The catheter is inserted through a small puncture made in the skin and placed into the blood vessel along a guide wire before injecting the contrast dye. If the tip splits or separates from the catheter, the tip could enter a patient’s bloodstream and cause serious injury or even death, according to the company. Surgery may be required to retrieve the tip. The catheter can also stop working if the tip splits or separates.
In July, Cook Medical issued a recall of 2,239 lots of the Beacon Tip Angiographic Catheters. At that time, the company had received 26 reports of its catheters malfunctioning and 14 were reports of adverse events, although the company did not describe those events. In its most recent announcement, Cook Medical did not say exactly how many medical devices were being recalled but in July, the company said that 95,167 versions of the Torcon, Royal Flush Plus and Slip-Cath catheters were subject to the global recall. Of that total, 38,895 catheters were being recalled in the United States.
[fda.gov/MedicalDevices/Safety/ucm457629.htm, July 2, 2015]
[fda.gov/Safety/Recalls/ucm457068.htm, August 3, 2015]
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.
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