Edwards Lifesciences recalls Swan Ganz Thermodilution Catheters with incorrect lumen assembly that may cause reversed pressure readings. Affected units have lot numbers 61176367 and 61176370. Contact for remedy.
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 incorrect lumen assembly that can cause reversed pressure readings. This could lead to inaccurate hemodynamic measurements and potentially incorrect medical decisions.
The catheters have incorrect lumen assembly, which can reverse the pulmonary artery and central venous pressure pathways. This causes clinicians to see reversed pressure values and waveforms, leading to potential misinterpretation of a patient's hemodynamic status.
Healthcare providers using Edwards Lifesciences Swan Ganz Thermodilution Catheters with lot numbers 61176367 or 61176370 are affected. Clinicians using these catheters for hemodynamic monitoring are most at risk of inaccurate readings.
Check for lot numbers 61176367 or 61176370 on the catheter packaging. These specific lot numbers are associated with the recalled units.
Verify the lot number on the catheter packaging to see if it is 61176367 or 61176370.
The catheters have incorrect lumen assembly that can cause reversed pressure readings and waveforms, leading to potential misinterpretation of hemodynamic status.
The recall record does not specify a remedy, so contact Edwards Lifesciences directly for guidance.
Yes, the recalled units have lot numbers 61176367 and 61176370.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0765-2019 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0765-2019 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.
