Recall Z-1322-2013 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.
| Date | May 14, 2013 (initiated Jan 25, 2013) |
| Status | Terminated |
| Reason | Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter. |
| Root cause | Device Design |
| Action | Edwards Lifesciences sent an Urgent Field Safety Notice letter dated February 1, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review entire inventory for the affected product, quarantine and return to Edwards. Contact Customer Services at 800-424-3278 for any question, to obtain a Returned Goods Authorization number and replacement product. |
| Quantity | 807 |
| Distribution | Worldwide Distribution - USA Nationwide including the states of: MD, NY, PA, CA, FL, AZ, AL, TX, VA, OH, MO, NC, GA, TN, CO, OR, SC, ME, IL, HI, NJ, WA, WI, CT, KY, LA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120780 | EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE Edwards Lifesciences, LLC, Jun 27, 2012 |