Edwards Lifesciences recalls FloTrac Sensor models MHD8, MHD85, MHD6R5, MHD8R, MHD8R5, MHD8S, and STERILEEO for potential flushing difficulties during pressure monitoring setup. Affected units have specific UDI and lot numbers.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Edwards Lifesciences is recalling FloTrac Sensors used in intravascular pressure monitoring due to potential flushing difficulties during setup with pressure transducers. This could affect medical procedures requiring accurate pressure readings.
The sensors may cause flushing difficulties when connecting to pressure transducers during setup. This could lead to inaccurate pressure readings or delays in medical procedures.
Healthcare providers using these sensors for intravascular pressure monitoring are most at risk. Patients receiving this monitoring may be affected if the sensors cause setup issues.
Check for the model numbers MHD8, MHD85, MHD6R5, MHD8R, MHD8R5, MHD8S, or STERILEEO on the device. Affected units have specific UDI and lot numbers listed in the recall notice.
Identify the model number on the FloTrac Sensor device to see if it matches the recalled models.
The recalled models are MHD8, MHD85, MHD6R5, MHD8R, MHD8R5, MHD8S, and STERILEEO.
The hazard is potential flushing difficulties during setup of the pressure monitoring kit with pressure transducers.
Check the model number on the device and compare it to the recalled models listed in the recall 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-0411-2024 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0411-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
