Edwards Lifesciences recalls Swan Ganz Thermodilution Catheters (REF 131F7P) with incorrect lumen assembly that may cause reversed pressure readings. Affected units include specific lot numbers.
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 (REF 131F7P) because they have incorrect lumen assembly. This can cause clinicians to see reversed pressure values and waveforms, which might lead to inaccurate hemodynamic readings during medical procedures.
The catheters have incorrect lumen assembly, which can cause the pulmonary artery and venous pressure readings to reverse. This may lead to incorrect hemodynamic assessments and potentially unsafe treatment decisions.
Healthcare professionals using the Swan Ganz catheters for hemodynamic monitoring are most at risk. Patients receiving these catheters during procedures may be affected if the pressure readings are inaccurate.
Check for the model number REF 131F7P in the product packaging. Affected units include specific lot numbers: 61321241, 61176369, 61176374, 61311580, 61176373, 61321254.
Identify the lot number on the catheter packaging to determine if it is affected.
The recalled model is REF 131F7P (5 pack of 131F7).
Affected lot numbers are 61321241, 61176369, 61176374, 61311580, 61176373, 61321254.
The catheters have incorrect lumen assembly, which can cause reversed pressure readings and waveforms during use.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0763-2019 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0763-2019 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.
