In 2015, the manufacturer of Beacon Tip Angiographic Catheters voluntarily recalled specific lots of the device after reports about catheter tips splitting or separating. Cook Medical in 2016 expanded the recall to all catheters with the Beacon Tip technology. The Class 1 recall, the most serious kind, involved more than 4 million catheters.
Problems with Cook Medical catheters surfaced shortly after they hit the market.
By 2016, the company had recalled more than 4 million Beacon Tip Angiographic Catheters after reports of tips splitting or separating.
This problem created the possibility of catheter tips entering patients’ blood vessels, causing serious injury or death and requiring medical intervention to retrieve the tip. Additionally, there was the probability of the device malfunctioning due to the splitting or separation.
Catheters are long thin, plastic tubes inserted into an artery through a small incision in the skin. Beacon Tip Angiographic Catheters were intended for use by physicians in the peripheral and coronary vascular system, including the carotid arteries, in angiographic procedures.
A catheter angiography requires the use of a catheter, X-ray imaging and often an injection of contrast dye to examine blood vessels in the body for abnormalities, such as plaque and other blockages, aneurysms, spasms or narrowing. The procedure is usually minimally invasive as well as efficient by assisting in the simultaneous diagnosis and treatment of a patient, thereby limiting patient exposure and back-to-back procedures.
A catheter angiography can be used to examine blood vessels throughout various components of the body including the respiratory system, digestive system, kidneys and urinary system, cardiovascular system, brain, neck, pelvis, legs and feet, arms and hands. The area where the catheter is to be inserted is shaved, cleaned and often numbed with a local anesthetic unless sedation is required. Catheter angiographies can last anywhere from less than an hour to several hours depending on the patient and the nature of the procedure.
Beacon Tip Angiographic Catheters were intended for use in the peripheral and coronary vascular system, including the carotid arteries, by physicians and qualified health care professionals in angiographic procedures.
Cook Medical received frequent reports of a problem called “polymer degradation.” That caused catheter tips to break. The catheters underwent a preliminary investigation that identified environmental conditions, such as storage temperature, humidity and the use of Vaporized Hydrogen Peroxide (VHP) for whole-room decontamination within health care facilities, as possible contributing factors to the malfunction.
Cook Medical decided to voluntarily recall its product following what it described as “an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.”
Polymer degradation is the breakdown of material from heat, oxygen and mechanical stress. Other environmental causes can cause the failure.
The company initially received 26 reports of the device malfunctioning, with 14 of those reports resulting in adverse events. That prompted a lot-specific recall on July 2, 2015. The recall was expanded in October 2015 for all lots of select sizes of catheters. It was expanded again in April 2016 to include all lots of catheters with Beacon Tip technology.
The voluntary global recall ultimately included a total of 4,146,309 catheters.
Cook Medical is presently in the midst of litigation for two of its other malfunctioning devices: its pelvic repair system products and IVC filters. The manufacturer’s pelvic repair system, which is implanted in women suffering from stress urinary incontinence or pelvic organ prolapse, contributed to Cook Medical being named as one of five vaginal device manufacturers facing personal injury claims said to have occurred as a result of the defective product. The consolidated case is currently pending in the Southern District of West Virginia, MDL No. 2440.
Additionally, Cook’s IVC filters were found in a study to have high rates of perforation, piercing the wall of the vein in which they were implanted. They were also found to frequently move from their original positions. Over 100 resulting lawsuits were consolidated into a multidistrict litigation (MDL) court in 2014 where the case is now pending in the Southern District of Indiana, MDL No. 2570.
Currently, Cook Medical is not facing any lawsuits regarding the malfunction of its Beacon Tip Angiographic Catheters. However, several law firms are presently seeking out consumers who may have a case against the company for harm caused by its defective catheters. Many law firms are still collecting client information and many consumers may still be presenting themselves as potential candidates with possible claims for damages as victims of serious injury or death resulting from the use of one of the affected catheters utilizing the Beacon Tip technology.
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