Z-0310-04

SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during...

Name: Z-0310-04 SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during...
Creator: Heartport Inc
Published: 2003-10-02
License: https://open.fda.gov/license/

Heartport, Inc. / initiated 2003-10-02 / Terminated

FDA source

Heartport Inc began a recall of SoftClamp II arterial cannula is intended to deliver oxygenated blood for cardiopulmonary bypass during surgery. The product also allows the hemostatic... on 2003-10-02. The reason FDA records is "Damaged hemostasis valves that prevent or present difficulty when inserting catheters". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0310-04
Status: Terminated
Initiated: 2003-10-02
Posted: 2004-01-09
Terminated: 2005-10-19
Recalling firm: Heartport, Inc.
Product: 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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Reason for recall: Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
FDA 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 in commerce: 26 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 consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
Product codes and lots: Lot numbers 030356, 050347, 060359.

Product code DWF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)