By Jessica Powell, Burg Simpson Associate
Catheters Used on Infants with Congenital Heart Disease Recalled
The FDA has issued a Class I recall, the most serious type of recall, of two heart catheters that are used to treat infants with congenital heart disease. The Miller Balloon and Fogarty Dilation Atrioseptostomy Catheters are used in some babies with congenital heart disease to improve the baby’s oxygen level or improve blood flow. The catheters work by using a balloon to enlarge the opening between the two upper chambers of the heart (the atria). On March 28, 2019, Edwards Lifescience issued an Urgent Product Recall because of the possibility of difficulty deflating the balloon after it is used, which can lead to the balloon fragmenting or detaching. This fragmenting and detaching can cause serious consequences, including damage to the heart, permanent disability, stroke, and death. Edwards Lifesciene has issued notices to healthcare providers that us the Miller Balloon and Fogarty Dilation catheters advising them to locate and remove any affected products from their inventory. To read the recall, click here.
Finding out that your child has a congenital heart condition is hard enough, but seeing your child injured during a procedure meant to treat that child’s condition is intolerable. If your child underwent an atrioseptostomy and was harmed by either of these products, contact one of the experienced products liability attorneys at Burg Simpson’s Cincinnati office today. Our award-winning attorneys would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.