The U.S. Food and Drug Administration announced on Wednesday, February 11, 2015, the initiation of an ongoing Class 1 recall of several models of Covidien’s Trellis 6 and Trellis 8 peripheral infusion systems, specifically manufactured at the company’s plant in Minnesota. These Trellis machines are used by doctors to remove blood clots in the deep veins of a patient’s thighs and calves. Blood clots that form in the legs can travel to the lungs. Blood clots in the lungs are life-threatening.
While A Class 1 recall is FDA’s most serious type of recall, reserved for defects that can cause harm to patients, the FDA did not report or disclose information about any patients being hurt, and Covidien says it has received no such reports. Covidien first informed hospitals about the the urgent recall notice on Dec. 15, 2014, and FDA classified the action as a Class 1 recall yesterday. The company says that last December it recalled 1,126 Trellis systems in the U.S. and 122 internationally, because it had received reports that the balloon ports on the outside of the machine were mislabeled.
Read more here: Covidien recalls blood-clot device, StarTribune FDA Recall Notice