Edwards Lifesciences is recalling the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter because of the possibility of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or detachment upon attempted retrieval.
No deaths have been reported, according to the Food and Drug Administration. However, one serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon, and the company says it has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including death.
The Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter enlarge the opening between an infant’s atris, the two upper chambers of the heart, to increase oxygenated/deoxygenated blood mixing, which then improves the baby’s overall oxygen level, or to decompress one of the atria when drainage is obstructed, to improves blood flow and cardiac output. But, the following complications could occur:
· heart damage to the inferior vena cava, and/or the femoral and iliac veins
· additional procedures to retrieve the fragments
· permanent patient disability
· pulmonary embolism
· stroke
· damage to other organs
· death
