Covidien Recalls Peripheral Infusion Systems Due to Production Error

Covidien is recalling more than a thousand Trellis 6 and Trellis 8 peripheral infusion systems due to a manufacturing error that caused the balloon inflation ports to be mislabeled. The error could cause physicians to deflate the balloons in the wrong order, causing blood clots to potentially dislodge and move into the lungs.

The Trellis 6 and Trellis 8 systems are used by healthcare providers to treat blood clots that form in the arms, hands, legs and feet. Once the balloons are inflated, isolating a clot, medication is released between them to dissolve the clot or reduce its size so it can be removed, a recall notice posted Tuesday to the FDA’s website says.

The FDA has designated the recall Class I, the most serious type.

The Plymouth, Minn., devicemaker notified customers in December, asking them to stop using the systems and return them to the company.

The recall includes 1,126 units distributed between June 6, 2014 and Nov. 13, 2014.

View the recall notice at http://www.fdanews.com/02-12-15-CovidienRecall.pdf. — Kellen Owings