Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of several congenital cardiac defects. Description of Use Balloon atrioseptostomy can be performed in conjunction with diagnostic cardiac catheterization or under echocardiographic guidanc

Product Description

Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an accepted technique for palliation of several congenital cardiac defects. Description of Use Balloon atrioseptostomy can be performed in conjunction with diagnostic cardiac catheterization or under echocardiographic guidance and has been carried out after the diagnosis of several congenital cardiac defects including but not limited to: transposition of the great arteries, total anomalous pulmonary venous drainage without pulmonary obstruction, tricuspid atresia, and pulmonary atresia with intact ventricular septum.

Details

Recalling Firm

Edwards Lifesciences, LLC

Units Affected

1093

Distribution

Worldwide Distribution - US Nationwide in the states of : IA, FL, MD, CA, NY, TX, CT, NC, OR, LA, UT,AK, WA, AZ, SD,CO,IN, KY, WV, TN, MI, AL, MA, VA, PA, MO, IL, GA, PR, MN, AR, OK, WI. Foreign (OUS): CL, AR, CZ, SG, BR, ID, ES, IE, GB, AT, CA, AM, HK, AU, ZA, FI, KR, MY, TH, NL, FR, IT, GR, DK, SE, DE, TR, QA, NZ, SA, PS, PT, JP, CH, IL, AE, BE, EE

Location

Irvine, CA