Edwards Lifesciences recalls FORE-SIGHT ELITE Tissue Ox: Inaccurate oxygen readings in arms/legs may lead to incorrect medical treatment. Affected units have specific serial numbers and model references.
The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude change. Low StO2 values may lead to unintended or inappropriate treatment
Edwards Lifesciences is recalling its FORE-SIGHT ELITE Tissue Oximeter module (REF: HEMFSM10) because inaccurate oxygen readings in arms or legs could lead to incorrect medical treatment. This affects patients using the device for monitoring oxygen levels in specific body areas.
The device may show falsely low oxygen levels in arms or legs, which could lead to unnecessary medical interventions. While the trend of oxygen changes is accurate, the magnitude of changes might be larger than normal, potentially causing incorrect treatment decisions.
Patients using the FORE-SIGHT ELITE Tissue Oximeter module for oxygen monitoring in arms or legs are affected. Those with medical conditions requiring precise oxygen measurements are at higher risk.
Check for the model reference HEMFSM10 on the device or its packaging. Affected units have specific serial numbers listed in the recall notice. The device is sold under Edwards Lifesciences.
Verify the model reference on the device or packaging to confirm if it matches HEMFSM10.
Reach out to Edwards Lifesciences for further assistance if you have the affected model.
The recall is due to the possibility of inaccurate oxygen readings in arms or legs, which could lead to unintended medical treatments.
Check for the model reference HEMFSM10 on the device or packaging. Affected units have specific serial numbers listed in the recall notice.
Contact Edwards Lifesciences directly for guidance on next steps.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0835-2022 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0835-2022 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.
