Introducer Sheath is indicated for patients requiring introduction of catheters. Introducer Sheath for EndoClamp, aortic catheter, 19Fr. IS19 (07042).
FDA Recall Z-0311-04 · Posted 2004-01-09
Recalling FirmHeartport Inc
Recall StatusTerminated
Product CodeDWF
Date Initiated2003-10-02
Date Terminated2005-10-19
Product Quantity13 units
Reason for Recall
Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K994253VACLOK SYRINGEMerit Medical Systems, Inc. · 2000-01-05K990772DIRECTFLOW ARTERIAL CANNULAHeartport, Inc. · 1999-03-23K974736HEARTPORT DIRECT AORTIC RETURN CANNULA WITH INTRODUCERHeartport, Inc. · 1998-07-15K972570HEARTPORT INTRODUCER SHEATHHeartport, Inc. · 1997-10-01K971291HEARTPORT ENDOARTERIAL RETURN CANNULAHeartport, Inc. · 1997-06-17K955121HEARTPORT ENDOARTERIAL RETURN CANNUALHeartport, Inc. · 1996-05-10
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.