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U.S. Department of Health and Human Services

Class 2 Device Recall SwanGanz Thermodilution Catheter

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  Class 2 Device Recall SwanGanz Thermodilution Catheter see related information
Date Initiated by Firm February 09, 2009
Date Posted April 17, 2009
Recall Status1 Terminated 3 on April 11, 2011
Recall Number Z-1238-2009
Recall Event ID 51492
510(K)Number K924661  
Product Classification Continuous Flush Catheter - Product Code KRA
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.
Code Information Lot: 58619364 - expiration date between May 2010 and November 2010.
Recalling Firm/
Manufacturer		 Edwards Lifesciences, Llc
1 Edwards Way
Irvine CA 92614-5688
Manufacturer 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".
FDA Determined
Cause 2		 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 35 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = BAXTER HEALTHCARE CORP.
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