Santa Cruz, CAAnother catheter was recalled last week, and this one got a Class 1 recall category, meaning the most serious kind.
The FDA recalled a bridge occlusion balloon catheter “due to the possibility of blocked guidewire lumen in select device units”. The Bridge Occlusion Balloon Catheter, made by Spectranetics, is designed to temporarily block the superior vena cava in the event of hemorrhage, according to the alert. The company sent a notice directing physicians to confirm that the guidewire lumen is open and unblocked prior to start of the procedure and to have backup units on hand, and the FDA stated that Spectranetics recommends health care professionals and patients report any adverse events or side effects related to the use of the product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
But what are the chances of a patient reporting an adverse event, given that the balloon catheter has been slapped with a Class 1 recall? The FDA defines this category as “ a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” Over 1,900 devices manufactured between Feb. 13 and July 18, 2017, and distributed between Feb. 24 and July 31, 2017, were recalled in the U.S., according to the agency. The amount of catheter recalls over the past few years is staggering: topping the biggest medical device recall in 2016 (according to medtechchina was Cook Medical's Single Lumen Central Venous Catheter Sets and Trays; Single Lumen Pressure Monitoring Sets and Trays; Femoral Artery Pressure Monitoring Catheter Sets and Trays; Radial Artery Pressure Monitoring Catheter Sets and Trays. And last October Vascular Solutions recalled more than 15,000 catheters.
Why are so many catheters recalled?
To start with, catheters are flexible tubes inserted through narrow openings into body cavity. The recalled catheters are not urinary catheters; those recalled are used for medical procedures, such as injecting dye for angiograms, or removing small blood clots from veins and arteries. According to the Journal of Medical Engineering & Technology the problem with the affected catheters is that they are prone to degrade and fracture. Tips and other components have broken or separated, resulting in serious patient injuries, and even in patient death. Once these fractures have broken loose, they can potentially float freely in the bloodstream and travel to the heart, lungs, or other vital organs. Hence a Class I recall.
But liability has yet to be definitively determined: At what point during manufacture have the catheter defects occurred? One law firm, Chandler Mathis Zivley, says that, “Investigators are now looking into the possibility that corners have been cut in attempts to streamline costs, resulting in products that are less sturdy and more prone to fail during use. One aspect of the investigation is focused on whether having products manufactured offshore, in an attempt to improve efficiency and lower costs, has resulted in inadequate testing and insufficient supervision that may underlie the problems.” Stay tuned…
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