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.
This recall has been terminated (originally issued April 17, 2009).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- February 9, 2009
- Posted
- April 17, 2009
- Terminated
- April 11, 2011
- Recall Number
- Z-1238-2009
- Quantity
- 35 units
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
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".
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.
Lot / Code Info
Lot: 58619364 - expiration date between May 2010 and November 2010.
Root Cause
Software design
Action Taken
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.