Edwards Lifesciences, Llc Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 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.
Brand
Edwards Lifesciences, Llc
Lot Codes / Batch Numbers
Lot: 58619364 - expiration date between May 2010 and November 2010.
Products Sold
Lot: 58619364 - expiration date between May 2010 and November 2010.
Edwards Lifesciences, Llc is recalling Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients who require h due to Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CT, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, MA, MI, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, WY, PR
Page updated: Jan 10, 2026