Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

SoftClamp II 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-ST II aortic catheter. SoftClamp II arterial cannula, 24Fr. SCK (06724). Cannulas are also packaged in kits with no specific lot numbers associated. The kits is identified as SoftClamp System, Product Code SC-24.

FDA Recall Z-0310-04 · Posted 2004-01-09

Recalling FirmHeartport Inc
Recall StatusTerminated
Product CodeDWF
Date Initiated2003-10-02
Date Terminated2005-10-19
Product Quantity26 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.

↑