Recall Z-0800-2020 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Edwards Lifesciences, LLC
QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705
| Date | Nov 27, 2019 |
| Status | Terminated |
| Reason | If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss. |
| Root cause | Other |
| Action | On 11/27/19, Urgent Medical Device Safety Notices were mailed to customers (Attention: Risk Management Departments). Customers were informed the following: 1. Review the field safety notice to understand the potential hazard. 2. Meet and review with the appropriate clinical staff at your hospital. 3. Complete and return the acknowledgment form attached to this letter via fax (949-250-2525). 4. Distribute this notice within your organization or to any organization where the devices under the safety alert have been transferred. 5. Make the information available to personnel that may be using |
| Quantity | 27168 |
| Distribution | U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. O.U.S. (Foreign): Brazil, Colombia, Albania, Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Czech Republic, Denmar |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981995 | QUICKDRAW VENOUS CANNULA Heartport, Inc., Apr 20, 1999 |