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).
- Company
- Heartport Inc Route
- Recall Initiated
- October 2, 2003
- Posted
- January 9, 2004
- Terminated
- October 19, 2005
- Recall Number
- Z-0308-04
- Quantity
- 209 units
- Firm Location
- Somerville, NJ
Reason for Recall
Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
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 consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
Lot / Code Info
Lot Numbers 020347, 030343, 060338, 080348
Root Cause
Other
Action Taken
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.