February 12, 2015 — A manufacturing error caused the balloon inflation ports to be mislabeled on Covidien’s Trellis 6 and Trellis 8 Peripheral Infusion systems, prompting a U.S. Food and Drug Administration (FDA) Class I recall of the devices.
The Trellis 6 and Trellis 8 Peripheral Infusion systems are used to treat blood clots that may form in the veins or arteries of the arms, hands, legs, or feet. The systems have two balloons that are inflated to isolate a clot. Medication is released between the balloons to reduce the size of or dissolve the clot so it can be removed. The FDA said the mislabeling may cause the physician using the device to deflate the balloons in the incorrect order. If this happens, there is a potential for blood clots to dislodge and move into the lungs. Depending upon the size of these clots, there is the possibility of serious patient injury or death.
The recall began in December and includes 1,126 units that were distributed in the United States from June 6, 2014 to November 13, 2014.
Customers were sent an urgent product recall letter dated Dec. 15, 2014. The letter identified the affected product and actions for customers. Customers should 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 Covidien Service at 1-800-716-6700.
For more information: www.fda.gov