Two Pediatric Cardiac Catheters Recalled for Defective Balloons
The US FDA says there’s been one serious injury, but no deaths, due to balloons deflating, fragmenting, or detaching.
Edwards Lifesciences is recalling two atrioseptostomy catheters due to problems associated with balloon deflation after deployment, as well as the possibility that the balloons may break apart and/or detach. The US Food and Drug Administration announced today that it has deemed it a Class I device recall, the most serious type.
The recall affects Miller Balloon Atrioseptostomy Catheters and Fogarty Dilation Atrioseptostomy Catheters model numbers 830515F and 830705F, which were distributed in the United States between January 9, 2018, and February 25, 2019. The catheters are used to enlarge interatrial openings during procedures to correct congenital cardiac defects, such as transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, and pulmonary atresia with intact ventricular septum.
Edwards says they are conducting an investigation to determine the cause of the problem.
“The firm 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,” the FDA advisory states. It describes one serious injury, in which an infant underwent “an invasive, but successful surgical procedure to retrieve a detached balloon.” No deaths have been reported.
US Food and Drug Administration. Edwards Lifesciences recalls Miller and Fogarty atrioseptostomy dilation catheters due to balloon deflation, fragmentation and detachment issue. Published on: April 26, 2019. Accessed on: April 26, 2019.