Beacon Tip Angiographic Catheters Recall Issued Due To Risk of Catheter Tip Splitting or Separating

   

Beacon Tip Angiographic Catheters Recall Issued By Cook Medical After Reports Of The Tip Separating From The Angiographic Catheter Potentially Causing Serious injury Requiring Recovery of The Tip, and may also cause death

Beacon Tip Angiographic Catheters RecallSouthern Med Law, which is currently representing patients who suffered serious injuries from medical devices in liability and personal injury lawsuits, has recently learned of the Beacon Tip Angiographic Catheters Recall after reports of tip serparation. Cook Medical, the Bloomington, Indiana-based medical device manufacturer, issued a voluntary recall on July 2, 2015 of its Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters. The Class 1 recall was initiated due to the company receiving 26 reports of the device malfunctioning. In 14 of those events, the Beacon tip split or separated from the catheter, according to Cook Medical’s news release. The splitting and/or separation can cause death or serious injury to a patient because the tip could enter the individual’s bloodstream which would require medical intervention to retrieve a separated segment or may block blood flow to end organs. Additionally, the company notified the U.S. Food and Drug Administration (FDA) and other regulatory agencies worldwide of the recall.
[fda.gov/MedicalDevices/Safety/ListofRecalls/ucm457629.htm, July 2, 2015]
[fda.gov/Safety/Recalls/ucm165546.htm, June 24, 2009]

“The law firm will continue to monitor the developments associated with Cook Medical’s recall of its angiographic catheters because the malfunction of these medical devices has serious and even fatal repercussions for patients,” says Dr. François Blaudeau, a founding partner of Southern Med Law.

Southern Med Law is conducting legal evaluations of Cook Medical Beacon Tip Angiographic Catheters Lawsuits. If have been harmed by a malfunctioning angiographic catheters or another medical device, you may be eligible to file a claim. To speak to one of the firm’s attorneys, please call 205-547-5525 or visit www.southernmedlaw.com and fill out the online form and for additional information

Beacon Tip Angiographic Catheters Recall

Cook Medical’s Beacon Tip Angiographic Catheters are used to inject contrast dye into blood vessels in the heart to prepare it for a type of X-ray used in cardiac angiograms, which are tests to diagnose heart conditions. 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. Cook Medical recalled 95,167 angiographic catheters worldwide, and the total included 38,895 devices recalled in the United States.
[fda.gov/Safety/MedWatch/SafetyInformation SafetyAlertsforHumanMedicalProducts/ucm457663.htm, August 7, 2015]

Class 1 recalls, like the one initiated by Cook Medical, are the most serious type of recalls 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 during recalls to let the public known that a medical device “may present an unreasonable risk of substantial harm.”
[fda.gov/Safety/Recalls/ucm165546.htm, June 24, 2009]

Prior to Cook Medical’s most recent recall, FDA records show that Cook Medical issued a recall in 2013 of its Zilver PTX Drug-Eluting Peripheral Stent, which is a self-expanding, small metal, mesh tube. The outer surface of the tube is coated with the drug Paclitaxel that is implanted in an artery of the thigh to help prevent the artery from narrowing again. According to Cook Medical’s news release, the company received complaints that the delivery system of the device had separated at the tip of the inner catheter.
[fda.gov/MedicalDevices/Safety/ucm353868.htm, April 18, 2013]

About Southern Med Law And Filing A Beacon Tip Angiographic Catheter 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
2224 1st Avenue North
Birmingham, Alabama 35203
Phone: 205-547-5525

Fax: 205-547-5526
francois@southernmedlaw.com
http://www.southernmedlaw.com
Medical Negligence/MedicalDevice/Pharma/Qui Tam

This entry was posted in Southern Med Law | Article. Bookmark the permalink.