Recall Z-0309-04 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Heartport Inc
DirectFlow arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. DirectFlow arterial cannula, 24Fr, Product Code DFK24 (06723). The cannulas are also packaged in kits that have no specific lot numbers associated. The kits are identified as th
| Date | Jan 9, 2004 (initiated Oct 2, 2003) |
| Status | Terminated |
| Reason | Damaged hemostasis valves that prevent or present difficulty when inserting catheters. |
| Root cause | Other |
| Action | Recall was first initiated on/about 10/2/03 by phone domestically from the Director of Marketing to the firm''s Sales Force (no phone script available). Following the initial phone call, formal recall letters were sent out on 10/6/03 to: Director of CV Suite; Director of the OR; and Director of Material Management of each hospital. |
| Quantity | 151 units |
| Distribution | Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955121 | HEARTPORT ENDOARTERIAL RETURN CANNUAL Heartport, Inc., May 10, 1996 |
| K971291 | HEARTPORT ENDOARTERIAL RETURN CANNULA Heartport, Inc., Jun 17, 1997 |
| K972570 | HEARTPORT INTRODUCER SHEATH Heartport, Inc., Oct 1, 1997 |
| K974736 | HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCER Heartport, Inc., Jul 15, 1998 |
| K990772 | DIRECTFLOW ARTERIAL CANNULA Heartport, Inc., Mar 23, 1999 |
| K994253 | VACLOK SYRINGE Merit Medical Systems, Inc., Jan 5, 2000 |