Edwards Lifesciences recalls Swan Ganz Thermodilution Catheters with incorrect lumen assembly (REF131F 7J) that may reverse pressure readings. Affected units have lot numbers 61321177 and 61227528. 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 model REF131F 7J due to incorrect lumen assembly. This can cause reversed pressure readings in medical monitoring, potentially leading to inaccurate hemodynamic assessments.
The catheter has reversed lumens, which can cause the clinician to see incorrect pressure values and waveforms. This may lead to wrong medical decisions about a patient's blood flow and heart function.
Healthcare providers using the Swan Ganz catheter for hemodynamic monitoring are most at risk. Patients receiving this monitoring may experience inaccurate blood pressure readings.
Check for the model number REF131F 7J on the catheter. Affected units have lot numbers 61321177 or 61227528.
Look for the model number REF131F 7J on the catheter.
The recalled model is REF131F 7J.
Lot numbers 61321177 and 61227528 are affected.
The catheter has incorrect lumen assembly that can cause reversed pressure readings.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0762-2019 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0762-2019 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.
