Medical devicemaker Covidien, now a part of Medtronic PLC, is recalling about 1,200 blood clot-removal devices that were made in Minnesota because errors in the machines' labeling can lead to serious patient harm.
On Wednesday, the Food and Drug Administration announced 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 plant. Class 1 is the FDA's most serious type of recall, reserved for defects that can cause harm to patients.
The FDA didn't disclose any cases of patients being hurt, and a company spokeswoman said it has received no such reports. The spokeswoman noted that hospitals were first informed of the urgent recall notice on Dec. 15, but the FDA classified the action as a Class 1 recall on Wednesday.
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.
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 known as deep-vein thrombosis, or DVT. If a DVT blood clot breaks free and travels to the lungs, the resulting pulmonary embolism may be fatal.
The combination of DVT and pulmonary embolism results in venous thromboembolism, a disease that kills as many as 300,000 Americans each year, according to a 2008 report from the not-for-profit healthcare-quality organization National Quality Forum.
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. It's a minimally invasive procedure performed using a small catheter threaded through the blood vessels to the site of the blood clot.
But if a doctor at the end of the procedure mistakenly deflates the two balloons in the wrong order, the remaining clot can break free and travel to the lungs, potentially injuring the patient, the FDA warned Wednesday.
A Covidien spokeswoman said the company 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 company's plant on Nathan Lane in Plymouth issued an urgent recall letter ordering all machines to be pulled out of use and sent back, even though there were no reports of patient harm.
Covidien was acquired last month by Medtronic in a $49.9 billion deal that consolidates operating headquarters of the companies in Fridley while moving its legal headquarters for tax purposes to Dublin, Ireland.
Joe Carlson • 612-673-4779
Twitter: @_JoeCarlson
