The FDA has made a voluntary recall of two peripheral infusion systems into a Class 1 recall.
Covidien notified its customers in December that it was recalling its Trellis-6 and Trellis-8 peripheral infusion systems because of a manufacturing flaw that resulted in the mislabeling of the proximal and distal ports. That error created the potential for a balloon to be deflated out of order, which would then put the patient at risk of developing an embolism.
Covidien had not received any reports of patient injuries.
Medtronic, which recently completed an acquisition of Covidien, announced the FDA’s classification on Feb. 12. The recall affects 1,248 devices that were made between January and November 2014 and distributed in the U.S., Europe, Australia, Canada and Turkey.
For the Trellis-6, the affected models include the BVT608010V01, BVT608030V01, BVT612010V01 and BVT612030V01. For Trellis 8, they are the CVT808015V01, CVT808025V01, CVT812015V01, CVT812025V01, EVT808015V01, EVT808025V01, EVT812015V01 and EVT812025V01.
Physicians should report any adverse events associated with these devices to the FDA. Medtronic plans to replace the recalled devices.