The medical device maker Covidien has recalled the Trellis 6 and Trellis 8 Peripheral Infusion systems because of a labeling error that could lead to patient injury or death.
The Trellis Peripheral Infusion system is used to treat blood clots that may form in the veins or arteries of the arms, hands, legs, or feet, the Food and Drug Administration (FDA) explains. The systems use two balloons that are inflated to isolate a clot. Medication released between the balloons reduces the size of or dissolves the clot so it can be removed. In the affected devices, the balloon inflation ports are mislabeled and if the balloons are deflated in the incorrect order, the blood clot could dislodge and move into the lungs. Depending on the size of the clot, there is the possibility of serious patient injury or death.
The FDA said that 1126 affected units were distributed in the U.S. from June 6, 2014 to November 13, 2014. The recalled units are Trellis 6 models BVT608010, BVT608030, BVT612010, BVT612030; and Trellis 8 models CVT808015, CVT808025, CVT812015, EVT808015, EVT808025, EVT812015V01, EVT812025V01. A full list of the lot numbers for recalled models can be found in the recall notice on the FDA web site.
Covidien sent customers an urgent product recall letter dated December 15, 2014, instructing them to discontinue use of the Trellis 6 and 8 infusion systems and return the systems to Covidien.
This is a Class I recall, the FDA’s most serious recall category, reserved for situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.