Concerns Over Catheter Recalls. Catheters are widely used medical devices that that are inserted into the body to facilitate a wide variety of treatments.
Catheters are used to drain urine and fluids from the body. Cardiac catheterization is a procedure used to examine heart function, take blood samples, take tissue samples for a biopsy, and sometimes to perform coronary angioplasty with stenting to open up narrowed or blocked segments of a coronary artery
Catheters are intended to unobtrusively perform their functions and be extracted with any lingering sign the catheter had ever been there. But 2016 has seen a rash of injury reports and catheter recalls, suggesting that a number of catheters are not performing as expected.
Personal injury law firm Parker Waichman notes that the catheter recalls in 2016, involve different firms and different types of catheters.
2016 Catheter Recalls
In March 2016, the Boston Scientific Fetch 2 Aspiration Catheter, a catheter used during procedures to remove small blood clots from coronary arteries, was recalled. There were reports of breakage along the catheter shaft during procedures to remove blood clots from peripheral veins and coronary arteries to restore blood flow to the heart. Pieces that break off can block the blood supply or migrate elsewhere in the body and result in injury or death.
The Food and Drug Administration (FDA) categorized this as a Class I recall, the agency’s most serious recall category. In a Class I recall, there is a reasonable probability that the use of or exposure to the product “will cause serious adverse health consequences or death.”
In April, Cook Medical initiated a global, voluntary recall of all catheters with Beacon Tip technology because of complaints of tip splitting and/or fracture. In October, device maker Centurion issued an urgent recall of its Centurion Convenience Kits containing Multi-Med Single Lumen Catheters distributed between May 23, and October 18 of this year. About 1,000 kits are affected.
The Centurion catheters are used for the sampling of blood, a standard medical procedure. The problem with these catheters is the excess material at the tip of the catheter from the manufacturing process. If the excess material breaks away from the catheter while it is in the the blood vessel, it could cause serious health consequences, including blood clots, embolisms or the migration of excess material to vital organs. The patient could die.
In June, Cook Medical recalled thousands of guidewires for percutaneous catheters because the coating may be contaminated with glass particles. The guidewires are used during insertion of the catheters in the arteries in the arms, legs, feet and hands. These catheters are used to drain fluid that has accumulated. Potential adverse events include blood vessel damage, bleeding, and the presence of blood clot particles in the circulatory system.
In another catheter recall, Vascular Solutions recalled the Twin-Pass Dual Access Catheters for the same reason as the Centurion catheter recall. Excess material was left at the tip of the catheter after the manufacturing process. The Vascular Solutions recall encompassed nearly 16,000 catheters distributed worldwide between October 2014 and September 2016. About a third of the recalled devices were distributed in the US. In October 2016, Medtronic recalled certain lots of its Pipeline embolization device, Alligator retrieval device, and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow and Marathon flow micro catheters.
The polytetrafluoroethylene (PTFE) coating on parts of these devices can separate from the catheter, releasing PTFE particles into the bloodstream. The particles could cause thromboembolism, a clot that forms in a blood vessel, breaks loose, and can block another blood vessel.
Catheter Fragment Leads to Death
The Dallas Morning News reported on the case of a 60-year-old Texas woman who had an 8-inch fragment of a plastic tube from a catheter left in her aorta during surgery in 2007. Hospital records indicate that the tube fragment was visible on X-rays from November 2007 but the woman’s family says they did not learn of the fragment until she suffered a heart attack and died in August 2016. According to the Morning News, surgery to remove the fragment was deemed too risky. The family’s earlier catheter lawsuit was dismissed but the woman’s husband has indicated that he will either appeal or retile the lawsuit in light of his wife’s death.
The Texas case highlights potential health risks posed by catheter fragments, even very small ones, left in the body.