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U.S. Department of Health and Human Services

Class 1 Device Recall Swan Ganz Thermodilution Catheter

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  Class 1 Device Recall Swan Ganz Thermodilution Catheter see related information
Date Initiated by Firm December 21, 2018
Create Date January 31, 2019
Recall Status1 Open3, Classified
Recall Number Z-0763-2019
Recall Event ID 81878
510(K)Number K160084  
Product Classification Catheter, flow directed - Product Code DYG
Product Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7)

Product Usage:
The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer. Swan-Ganz thermodilution catheters are indicated for the assessment of a patient s hemodynamic condition through direct intra-cardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Code Information Lot Numbers: 61321241, 61176369, 61176374, 61311580, 61176373, 61321254  
Recalling Firm/
Manufacturer
Edwards Lifesciences, LLC
1 Edwards Way
Irvine CA 92614-5688
For Additional Information Contact Michael Collins
949-250-6339
Manufacturer Reason
for Recall
The product is being recalled as result of a non-conformance involving Swan Ganz catheters with incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Edwards sent an Urgent Product Recall letter to affected customers on 12/21/2018. The letter identified the affected product, problem and actions to be taken. Customers were instructed to the return any unused units that are currently in their inventory. Once returned, replacement product will be shipped at no charge. Customers were asked to complete the attached acknowledgement form. For questions contact Edwards Technical Support at 1-800-822-8837 option 1.
Quantity in Commerce 875 units
Distribution Worldwide Distribution
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DYG and Original Applicant = Edwards Lifesciences, LLC
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