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U.S. Department of Health and Human Services

Class 1 Device Recall Fogarty Dilation Atrioseptostomy Catheter

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  Class 1 Device Recall Fogarty Dilation Atrioseptostomy Catheter see related information
Date Initiated by Firm March 28, 2019
Date Posted April 25, 2019
Recall Status1 Terminated 3 on November 01, 2023
Recall Number Z-1116-2019
Recall Event ID 82455
Product Classification Catheter, septostomy - Product Code DXF
Product 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.
Code Information All lots within 15 months expiry from 03/01/2019
Recalling Firm/
Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Linnette Torres
Manufacturer Reason
for Recall
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
FDA Determined
Cause 2
Process design
Action On 03/28/19, Urgent Product Recall - Action Required Field Corrective Action notices were mailed FedEx Second Day to customers. The letter identified the affected product problem and actions to be taken. The firm is requesting the return of any existing inventory of these models. They are conducting an investigation of the issues. At this time, they do not have an estimated date as to when replacement product will become available. The firm urges customers to inquire as to the availability of similar products. Customers with additional questions are encouraged to call 800-424-3278 Option 1. Firm requests that customers fill out and return Customer Acknowledgement forms within 10 days of receipt of this notification.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.