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FDADecember 21, 2018device

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 thermodilu...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

edwards lifesciencesedwards

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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