Edwards Lifesciences has voluntarily recalled the Miller Balloon Atrioseptostomy Catheter and Fogarty Dilation Atrioseptostomy Catheter. The FDA has identified this as a Class I recall, the most serious type of recall, because the use of these devices may cause serious injuries or death.
Which Catheters are Affected
The recall affects Miller Balloon Atrioseptostomy Catheters and Fogarty Dilation Atrioseptostomy Catheters with model numbers 830515F and 830705F under 60 different lot numbers. The devices were manufactured between Dec. 22, 2017, to Jan. 18. 2019, and distributed between Jan. 9, 2018, and February 25, 2019.
Use of the Catheters
The devices are used to correct complex congenital heart defects in infants. They 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 Reason for the Recall
Edwards recalled the two atrioseptostomy cardiac catheters due to the potential for difficulty in deflating the balloon after it is deployed, which could cause it to fragment or detach during retrieval. The firm has received reports of the balloon fragmenting or detaching, which may cause serious adverse health consequences.
Dangers of the Catheters
The FDA said these issues presented by the catheters could cause the following serious health complications
- Damage to the heart, the inferior vena cava or the femoral and iliac veins
- Permanent patient disability
- Pulmonary embolism
- Damage to other organs
Talk to Us About the Recall
Has your infant undergone a procedure involving the Miller Balloon Atrioseptostomy Catheter or the Fogarty Dilation Atrioseptostomy Catheter? Jason J. Joy & Associates has years of experience navigating complex medical lawsuits at the federal level. Contact us now to discuss your potential case.
Read more about the catheter recall here.