Edwards Lifesciences recalls FloTrac Sensor with Vamp System (MHD6AZ, MHD6AZ5, MHD6C502) for potential flushing difficulties during pressure monitoring setup. Affected units have specific lot numbers and require medical use only.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Edwards Lifesciences is recalling FloTrac Sensor with Vamp System devices that may cause flushing difficulties when setting up pressure monitoring kits. This could affect patients using intravascular pressure monitoring systems.
The device may cause flushing difficulties during setup of the pressure monitoring kit with the pressure transducer. This could lead to improper pressure readings or complications in monitoring a patient's blood pressure.
Patients using intravascular pressure monitoring systems with the recalled FloTrac Sensor devices. Healthcare providers who administer these devices are most at risk.
Check for the model numbers MHD6AZ, MHD6AZ5, or MHD6C502 on the device. The lot numbers listed in the recall notice are specific to each model. These devices are for medical use only and require a prescription.
Identify the model number (MHD6AZ, MHD6AZ5, or MHD6C502) on the device.
Consult with your healthcare provider to determine if you have the recalled device and whether a replacement is needed.
The device may cause flushing difficulties during setup of the pressure monitoring kit with the pressure transducer, which could lead to improper pressure readings.
Check for the model numbers MHD6AZ, MHD6AZ5, or MHD6C502 on the device. The lot numbers listed in the recall notice are specific to each model.
No, the recall does not require immediate discontinuation. However, you should contact your healthcare provider to determine if a replacement is needed.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0412-2024 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0412-2024 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.
