Edwards Lifesciences recalls TruWave Vamp System Pressure monitoring sets with potential flushing difficulties during setup. Affected models include PXAVMP and variants with specific sizes and UDI lots. No remedy specified in recall notice.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Edwards Lifesciences is recalling certain TruWave Vamp System Pressure monitoring sets due to potential flushing difficulties during setup. This could affect medical use and requires verification of the specific model and lot numbers.
The hazard involves potential flushing difficulties during setup of the pressure monitoring kit with the pressure transducer. This could lead to improper medical monitoring if the system does not function correctly during setup.
Patients using these pressure monitoring sets for medical purposes are most at risk. The recall affects specific models and sizes sold with unique UDI and lot numbers.
Check for model numbers like PXAVMP, PXAVMP3, PXVK0364, and other variants listed in the recall. Look for specific sizes (e.g., 68 in, 76 in) and UDI lot numbers provided in the recall notice.
Verify your TruWave Vamp System Pressure monitoring set model and size against the list of affected models and sizes provided in the recall notice.
The recall applies to specific TruWave Vamp System Pressure monitoring sets with potential flushing difficulties during setup. Check your model and size against the list provided in the recall notice.
The recall notice does not specify a remedy. You should check your product details against the list of affected models and sizes to determine if it is included.
Look for model numbers like PXAVMP, PXAVMP3, PXVK0364, and other variants listed in the recall. Check the size (e.g., 68 in, 76 in) and UDI lot numbers provided in the notice.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0414-2024 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0414-2024 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.
