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.
A manufacturing error caused the balloon inflation ports to be mislabeled. The proximal and distal balloon inflation ports were labeled incorrectly, resulting in the potential for an incorrect sequence of balloon deflation. If the physician using the device were to mistakenly deflate the balloons out of order, there is a potential for blood clots to travel downstream and become lodged in the lungs. Depending upon the size and location of these clots, there is the possibility of serious patient injury.
The recall involves 1,248 units manufactured and distributed by Covidien from January 2014 to November 2014. Covidien learned of this issue through customer reports identifying incorrect balloon port identification.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death