Covidien Trellis Clot-Busting Device Recalled Due to Labeling Mishap
Covidien is recalling about 1,100 blood clot-removal devices that were manufactured in Minnesota because errors in the machines’ labeling can lead to serious patient harm.
About the Trellis Clot-Busting Device Recall
According to the MassDevice, there is an ongoing Class 1 recall of a dozen models of Covidien’s Trellis 6 and Trellis 8 peripheral infusion systems, made at the company’s Plymouth, MN plant. Class 1 is the FDA’s most serious type of recall, reserved for defects that pose a significant risk of injury or death to patients.
Trellis infusion systems are designed to address an underlying factor in one of the most common preventable causes of death in U.S. hospitals, venous thromboembolism. When a blood clot breaks loose and travels in the blood, this is called a venous thromboembolism (VTE).
Doctors can use Trellis machines to remove blood clots blocking the flow of blood in deep veins in a patient’s thighs and calves, a condition better known as deep-vein thrombosis, or DVT. If a DVT blood clot breaks free and travels to the lungs, the resulting pulmonary embolism could potentially be fatal.
The Trellis system can also be used to remove clots in the arms, hands and feet, not just the legs. It works in all cases by trapping the clot between two balloons inside the affected blood vessel, and then injecting a drug to dissolve it, before removing any remaining material.
The recall was caused by a manufacturing error, and the balloon inflation ports ended up being mislabeled. If a doctor at the end of the procedure mistakenly deflates the two balloons in the wrong order, the remaining clot(s) can break free and travel to the lungs. Depending upon the size of the clots, there is the possibility of serious patient injury or even death.
Description of Recalled Devices
- There were no cases of patients being hurt, and the company has received no such reports.
- The hospitals were first informed of the urgent recall notice on December 15, but the FDA classified the action as a Class 1 recall on Wednesday.
- Covidien decided to recall its 1,126 Trellis systems in the U.S. and 122 internationally in December after customers reported that the balloon ports on the outside of the machine were mislabeled, creating the potential for a mix-up. The Trellis devices were distributed sometime between June 6 and November 13, 2014.
- Covidien’s plant on Nathan Lane in Plymouth, MN issued an urgent recall letter ordering all machines to be pulled out of use and sent back to the company’s facility immediately.
- Here is a list of the products being recalled: Trellis 6/Model BVT608010, Trellis 6/Model BVT608030, Trellis 6/Model BVT612010, Trellis 6/Model BVT612030, Trellis 8/CVT808015, Trellis 8/CVT808025, Trellis 8/CVT812015, Trellis 8/CVT812025, Trellis 8/EVT808015, Trellis 8/EVT808025, Trellis 8/EVT812015V01, and Trellis 8/EVT812025V01.