Recall Z-2188-2012 ยท DYG Catheter, Flow Directed
Edwards Lifesciences, LLC
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
| Date | Aug 12, 2012 (initiated May 11, 2012) |
| Status | Terminated |
| Reason | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. |
| Root cause | Process control |
| Action | Edwards Lifesciences sent a "PRODUCT RECALL" letter dated May 8, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Confirmation Form was attached for customers to complete and return via fax to 1-800-422-9329. Contact Customer Service at 1-800-424-3278 for questions regarding this notice. |
| Quantity | 32,145 units for all products in Recall Event |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810352 | SWAN-GANZ FLOW-DIRECTED THERMODILUTION American Edwards Laboratories, Mar 27, 1981 |