Edwards Lifesciences recalls Swan Ganz Thermodilution Catheters with REF 131VF7P due to incorrect lumen assembly that may cause reversed pressure readings. Affected units were sold with lot number 61176314.
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.
Edwards Lifesciences is recalling Swan Ganz Thermodilution Catheters with reference number 131VF7P because they have incorrect lumen assembly. This could lead to reversed pressure readings during medical use, potentially causing misdiagnosis of a patient's hemodynamic condition.
The catheters have incorrect lumen assembly, which may cause the pulmonary artery and venous pressure readings to reverse. This reversal could lead to misdiagnosis of a patient's hemodynamic condition, such as cardiac output or blood pressure levels.
Healthcare professionals using the Swan Ganz catheters for hemodynamic monitoring are most at risk. Patients receiving treatment with these catheters could experience incorrect pressure readings.
Check for the reference number 131VF7P on the catheter. Affected units were sold with lot number 61176314.
Inspect the catheter for proper lumen assembly to ensure pressure readings are accurate.
The recalled catheter has reference number 131VF7P.
Reversed lumens may cause the clinician to see incorrect pressure values and waveforms, leading to potential misdiagnosis.
Check for the reference number 131VF7P and lot number 61176314 on the catheter.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0764-2019 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0764-2019 from Edwards Lifesciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
