Z-1239-2009

Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an...

Name: Z-1239-2009 Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an...
Creator: Edwards Lifesciences, Llc
Published: 2009-02-09
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2009-02-09 / Terminated / root cause: software

FDA source

Edwards Lifesciences, Llc began a recall of Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance... on 2009-02-09. The reason FDA records is "Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1239-2009
Status: Terminated
Initiated: 2009-02-09
Posted: 2009-04-17
Terminated: 2011-04-11
Recalling firm: Edwards Lifesciences LLC
Product: Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output.
Product code: KRA Catheter, Continuous Flush
Reason for recall: Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".
Root cause tag: software
FDA root cause: Software design
Action: Edwards initiated the worldwide recall via Urgent Customer Notification letters dated February 9, 2009 and are being sent by Federal Express starting on February 10, 2009. These letters are requesting that customers cease using Swan-Ganz" Continuous Cardiac Output (CCO) Thermodilution Catheter products from the indicated lots and that they return all unused product. Edwards Lifesciences requested that the customer provide written verification of stock and identify any unused product to be returned. Questions should be directed to Technical Service at 800-822-9837.
Quantity in commerce: 107 units
Distribution: Worldwide Distribution -- AL, AR, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Hawaii, and Puerto Rico and countries of Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, UK, Greece, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Portugal, Sweden, Colombia, Australia, and Singapore.
Product codes and lots: Lot 58619322 - expiration date between May 2010 and November 2010.

Product code KRA

K924661Class IISwan-Ganz Intellicath Cco Thermodilution CatheterBaxter Healthcare Corp / cleared 1993-04-08

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)