FDA Recalls Cordis Angiographic Catheters Over Danger of Dislodging

The U.S. Food & Drug Administration (FDA) has classified this as a Class I recall, the most serious type. The agency classified this recall under this category because of the product’s potential to cause serious injury or death. To date, no one has filed lawsuits against the company. However, due to the seriousness of the risks involved, it is likely that Cordis may face litigation over these defects.

What are Cordis Angiographic Catheters?

Cardiac catheterizations are quite common, with almost one million procedures conducted in the United States per year. Doctors use cardiac catheterizations to diagnose heart and blood vessel conditions. Physicians typically use these devices during angiographic procedures to visualize and measure parts of the vascular system. They used the devices with radiopaque (X-ray detectable) contrast media. Physicians inserted angiographic catheters into the arteries to examine a patient’s vascular system and the insides of their blood vessels. From this procedure, physicians can view evidence of aneurysms, pulmonary embolisms, plaque build-up, aortic dissection, and other vascular issues. Angiographic catheters are also used to assess the extent of conditions including stenosis, coronary artery disease, and congenital heart disease.

Device Defects

The angiographic catheters that are the subject of the recall are lined with gold-alloy marker bands. Because these bands are visible via X-ray, they help physicians monitor the catheter placement during the procedure and perform measurements. The bands, however, are the cause of the device’s defects. They can move during the procedure, lose their position, come loose from the catheter, or cause delays in angiographic procedures. They can also cause serious health risks such as heart attack or stroke. Furthermore, band defects could result in the need for additional procedures.

Recall History

So far, there have been 167 complaints and eight reported injuries related to the use of these devices. No deaths have been reported. Cordis initiated the recall back in May and later issued an “Urgent Medical Device Field Correction” letter to its customers. The letter detailed a description of the problem. As Cordis explains in its August 4, 2021 letter, the Super Torque MB Angiographic Catheters are being used in a way that may cause the catheter to become entrapped between endovascular devices and the vessel wall. If the device becomes entrapped, the marker bands may stretch or elongate enough to cause movement or dislodgement of the catheter itself.

These incidents occur more frequently during EVAR/covered stent procedures (also known as endovascular aneurysm repairs). The letter added a warning in its “Instructions for Use.” The warning stated that physicians should not use the devices in procedures where entrapment of the catheter may occur. It also provided recommendations for clinical use of the device. Notably, Cordis is not attributing the dangers to a manufacturing defect, but rather, misuse of the product. Therefore, the company is not requesting the return of the devices.

In September, the FDA issued the recall notice. The recall affects 25,000 devices that the company distributed between January 1, 2019 and July 20, 2021. This includes the Super Torque MB 5F Pig and the 5F Super Torque Pig Pigtail Special. The recall also encompasses the 5F Universal Flush F4 Super Torque MB Special. The recall does not involve devices that do not come with marker bands.

Lawsuits Against Cordis Angiographic Catheters

There have yet to be any lawsuits filed against Cordis concerning its angiographic catheters. However, this would not be the first time the company’s devices were the subject of litigation. Earlier this year, Cordis was facing over 400 lawsuits related to its vena cava filters. Physicians used these products to treat blocked arteries in the lungs.

In August, just weeks before the FDA released its angiographic catheter recall, the FDA issued two Class I recalls of other Cordis devices. The recall covered Argyle UVC Insertion Tray and Safety Scalpel N11 and its line of Monoject Flush Prefilled Saline Syringes. The Argyle UVC Insertion Tray organized tools for procedures involving catheter insertion into a critically ill newborn’s umbilical artery. The kit’s scalpel included a safety feature that permanently locks the blade, rendering the device useless in emergency situations. There have been two deaths reported from physicians unable to unlock the scalpel during emergency procedures.

The Monoject Flush Prefilled Saline Syringes, prefilled with saline solution, flushed out intravenous tubing systems and intravascular access devices. According to the notice, the mechanism of the syringes may cause excess air into the syringe. The syringe could then inject excess air into the patient’s blood vessels. This could cause an air embolism, stroke, heart attack, or respiratory failure.

How Can Experts Weigh In On Cordis Angiographic Catheters?

The question of whether a patient can successfully sue Cordis for damages resulting from these angiographic catheters is still in its infancy. With no lawsuits filed just yet, it is likely that affected patients might not know the cause of their injuries. As of now, Cordis maintains that any injuries would be the result of product misuse, opposed to manufacturing defects. Attorneys would need the expertise of qualified vascular surgeons and cardiologists. Cardiologists specialize in heart disease and the cardiovascular system. Vascular surgeons specialize in the entire vascular system. The experts could determine the standard of care when using these devices. The experts could also determine if misuse actually is a factor in causing injury.

Whether these catheters are defective is a question for catheter manufacturing experts as well as regulatory experts. One possibility may be that Cordis insufficiently tested the catheters before entering the market. This possibility has become more likely in light of the growing number of catheter recalls throughout the country. Therefore, the manufacturing and testing process, including any clinical trials, may play a role during any subsequent Cordis catheter litigation.

Overall, the potential injuries to patients in these cases are too grave and will likely warrant litigation in the future.