Recall Z-0308-04 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Heartport Inc
EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 23 Fr. Product code ER23 (07044).
| 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 | 209 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 |