Earlier this year, a woman from Texas died at the age of 60 when an 8-inch fragment of a catheter was left in her heart in 2007. Her husband filed a lawsuit against the hospital for failing to remove it for seven years.
She is not alone — dozens of people have been injured by broken catheters, and millions of them have been recalled this year.
A catheter is a flexible plastic tube that is inserted in the body to collect or deliver fluid. For example, a urinary catheter collects urine from the bladder, while a cardiac catheter delivers a special dye that is visible in an X-ray.
The largest catheter recall was issued on April 15 by Cook Medical. Over 4.1 million Beacon-Tip catheters because the tip could break off. The FDA reported at least 30 injuries.
On April 19, Boston Scientific recalled the Fetch 2 Aspiration Catheter because the shaft could break during surgery to remove blood clots.
On December 9, another recall was issued for Centurion Convenience Kits containing Multi-Med Single Lumen Catheters, which were used to draw blood or administer medications or fluids. According to the FDA:
Excess material may separate from the catheter during use and could enter the patient’s bloodstream. This can result in serious adverse health consequences such as the development of blood clots, embolism of the excess material to vital organs, or death.”
On October 4, the FDA also recalled Vascular Solutions Twin-Pass Dual Access catheters. The catheters had the same problem as the Centurion recall — excess material in the tip, which poses a risk of blood clots and death.
On November 30, Medtronic recalled several catheters that are used to treat blood clots in the brain. The problem was that the coating on the catheter could peel off and enter the bloodstream, causing blood clots.
The recall included the Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, UltraFlow micro-catheters, and Marathon micro-catheters, according to the Wall Street Journal.
Source: Dallas Morning News