Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ga...
FDA Recall #Z-0762-2019 — Class I — December 21, 2018
Product Description
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J 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.
Reason for Recall
These Swan Ganz catheters have 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.
Recalling Firm
Edwards Lifesciences, LLC — Irvine, CA
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
277 units
Distribution
Worldwide Distribution
Code Information
Lot Numbers: 61321177, 61227528
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated