Recall Z-0991-2011 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences Llc
EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614. The EndoPlege coronary sinus catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible w
| Date | Jan 28, 2011 (initiated Dec 3, 2010) |
| Status | Terminated |
| Reason | Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury. |
| Root cause | Device Design |
| Action | The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated December 3, 2010 to customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to check their inventory and return the unused devices; complete and return the INTROCSC Introducer Recall Response form to the attention of Customer Service, Edwards LifeSciences, One Edwards Way, Irvine, CA at 949-250-3489. If you have any questions, please contact Edwards Customer Service at 800-424-3278 from 8:00am - 4:30pm Pacific Time. |
| Quantity | 3,427 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964248 | HEARTPORT ENDOCORONARY SINUS CATHETR Heartport, Inc., Jan 22, 1997 |