Two of Edwards Lifesciences’ pediatric catheters are facing a Class I recall. The Irvine, CA-based company’s Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter are in a Class I recall because of the possibility of difficulty in balloon deflation after deployment.
The balloon deflation could lead to balloon fragmentation or detachment upon attempted retrieval. Edwards said it has received reports of balloon fragmentation or detachment, which may cause serious adverse health consequences including: damage to the heart, 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; or death.
One serious injury was reported in which an infant underwent an invasive, but successful surgical procedure to retrieve a detached balloon, according to a release from FDA’s website. There were no deaths reported.
The Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter are used by health care providers to enlarge the opening between the two upper chambers of the heart (the atria).
This is done either 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, which then improves blood flow and cardiac output.
The recall comes shortly after competition intensified for transcatheter aortic valve replacement procedures – a market Edwards is a pioneer in. Just last week, Boston Scientific entered the U.S. market with FDA approval for its Lotus Edge Valve.
Now Edwards squares off against Medtronic and Boston Scientific in both the U.S. and Europe markets.