Catheter Recalls Number into the Millions. Will Lawsuits Follow?

Washington, DCWith some four million allegedly defective catheters having been recalled from the market, such a number extrapolated across risk factors suggest defective catheters causing injury lawsuits will result, given the number of fairly common medical procedures for which catheters are routinely employed.

The usefulness and benefit of catheter devices is not in dispute, given the wide range of applications and indications for which the catheter is used: administration of medications, injecting contrast dye for angiogram procedures, or removing small blood clots (thrombectomy) from veins and arteries. 

The problem has appeared to be the degradation of catheters, and catheter components, which foster fracture events involving catheter tips and similar events involving component fracture or separation, resulting in death or serious injury for some patients when material, or pieces of components inherent with the catheter break away from the catheter and are left to float freely in the bloodstream.

Were this free-floating material to migrate to the heart, lungs or other vital organs, the outcome could be catastrophic.

Several manufacturers have recalled various models, and lots of catheters – including Cook Medical, Boston Scientific, and Centurion. Medtronic and Vascular Solutions are two other manufacturers having triggered recalls.

Pundits wonder about the issue at the center of the recalls, and the allegedly defective catheters.

Are decisions related to manufacturing, to blame? Are efficiencies employed in the manufacturing process in order to streamline costs leading to products that are less robust, and more failure-prone than their predecessors?

The field of medicine – including medical devices – is constantly evolving, through the development of new procedures, together with new and improved devices. Manufacturers, like all private corporations in the US, are intended to earn profits for shareholders. The manufacturing industry in general has found a myriad of efficiencies by having their products made off-shore, with new materials not sufficiently tested over long-term use.

The 510(k) Clearance maintained by the US Food and Drug Administration (FDA) is a loophole through which plenty of device manufacturers have jumped, in order to bring a product to market more quickly. Originally intended by the FDA to get promising products in the hands of doctors and their patients more quickly, the 510(k) Clearance allows a manufacturer to update an existing product provided the design is inherently similar to that which is already on the market and performing well.

What this means, is an updated product through a 510(k) clearance escapes the kind of rigorous clinical testing and trials the original device, originally put forward as a new and unique design without equal or precedent, is required to undergo.

Medical devices which leave fragments behind in the human body risk a host of potential problems and complications for the patient, given the challenges involved with locating, and retrieving potentially small fragments that can foster major harm to a patient.

Meantime, the Fetch 2 Aspiration Catheter, the Shuttle Select Slip-Catheter, and the Beacon catheters, are just some of the devices recalled.