Edwards Lifesciences recalls Fore-Sight Elite Absolute Tissue Oximeters with model 01-06-3000 due to potential inaccurate low oxygen readings in arms/legs, which could lead to unintended medical treatments.
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 Fore-Sight Elite Absolute Tissue Oximeters with model number 01-06-3000 because they may show falsely low oxygen levels in arms or legs. This could cause doctors to give unnecessary treatments. The recall affects patients using these devices for monitoring oxygen levels.
The device may show inaccurate low oxygen readings in arms or legs, which could lead to doctors giving unnecessary treatments. While the trend direction remains accurate, the magnitude of changes might be larger than normal, potentially causing unintended medical interventions.
Patients using the Fore-Sight Elite Absolute Tissue Oximeter for oxygen monitoring are most at risk. The recall applies to those with the specific model number 01-06-3000.
Check for the model number 01-06-3000 on the device or its packaging. The recall includes all units with this specific model and serial numbers.
Look for the model number 01-06-3000 on the device or its packaging to confirm if it is affected.
The device may show inaccurate low oxygen readings in arms or legs, which could lead to unintended medical treatments.
The model number 01-06-3000 is affected.
No, the device can continue to be used but users should check for inaccurate readings in arms or legs and consult their healthcare provider if concerns arise.
We’ve drafted a message you can send Edwards Lifesciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0834-2022 — Edwards Lifesciences Edwards Lifesciences Hello, I own a Edwards Lifesciences that is covered by recall Z-0834-2022 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.
