2 of Edwards & #039; Pediatric Catheters Face Class I Recall

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. Join us for New England’s Premier Medtech Event Held at the Boston Convention Exhibition Center in Boston, MA, May 15-16. 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 ox...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Regulatory and Compliance Source Type: news