Covidien has recalled its Trellis 6 and Trellis 8 Peripheral Infusion systems due to a labeling issue, according to a recall notice posted on the U.S. Food and Drug Administration’s (FDA’s website). The recall was classified as Class I, which is the agency’s most serious recall status. Class I recalls mean that there is a reasonable risk of serious injury or death.
The systems are used to treat blood clots in the veins or arteries of the arms, hands, legs or feet; two balloons are inflated on either side of a clot while medication is released between them. This process allows the clot to be reduced or dissolved so it can be removed.
According to the recall notice, the balloon inflation ports were mislabeled due to a manufacturing error. As a result, physicians may deflate the balloons in the wrong order and possibly allow the blood clots to dislodge and move into the lungs. This can lead to serious injury or death, depending on the size of the clot.
The recall was issued on Dec. 10, 2014, the notice states. Between Jun. 6, 2014 and Nov. 13, 2014, 1,126 units were distributed in the U.S. Urgent product recall letters dated Dec. 15, 2014 were sent to customers identifying the product and actions. “Customers were instructed to discontinue the use of the Trellis 6 and 8 infusion systems and return it to Covidien along with a response form included in the letter. Customers with questions should contact their Covidien sales rep or to Covidien Service at 1-800-716-6700.” the notice said.