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Texas Personal Injury News

Monday, January 30, 2017

Millions of Defective Catheters Recalled

How does the FDA’s 501(k) clearance rule put consumers at risk?

Four million catheters reported to be defective have been recently recalled. Because catheters are used in so many common medical procedures, it is expected that many personal injury lawsuits are in the offing. If you have suffered a personal injury as the result of catheter usage, you should contact a skilled defective drug and medical device attorney to advise you of your best options. An experienced personal injury lawyer will help you to obtain the compensation you’re entitled to.

What are catheters?

Catheters are flexible tubes inserted through a narrow openings into body cavity. Though most people think of urinary catheters first, the catheters that have been recalled are those used for other medical procedures, such as injecting dye for angiograms, or removing small blood clots from veins and arteries (thrombectomies).

The Defect in the Devices

The problem with the affected catheters is the fact that they are prone to degrade and fracture. There have been incidents in which catheter tips and other components have broken or separated, resulting in serious patient injuries, and even in patient death. The riskiest aspect of these fractures is that parts of the catheter, once broken loose, are capable of floating freely in the bloodstream and traveling to the heart, lungs, or other vital organs. The presence of these flecks of foreign matter in these organs can be disastrous.

Questions of Liability

It has not yet been definitively determined at what point during manufacture the catheter defects occurred. Many manufacturers have recalled various models of a great many catheters. These manufacturers include Cook Medical, Boston Scientific, Centurion, Medtronic, and Vascular Solutions. 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.

Why 510(k) Clearance Is Problematic for Consumers

Because the field of medicine in this country is profit-driven as well as life-giving, manufacturers are always trying to lower their bottom line at the same time as they create and improve medical devices. This can sometimes result in insufficiently tested materials hitting the market.

Of concern to many is the 510(k) Clearance, a loophole of the U.S. Food and Drug Administration (FDA) designed to allow medical products to come to market more quickly.

This regulation, to the dismay of some who seek to protect the public, allows an existing product to be updated without rigorous clinical testing if its design is similar to that of the device already on the market. Unfortunately, there is room in the 510 (k) clearance for missing alterations that may present serious risks to patients.

 


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