The Recall Desk
HighFDA (Devices)·Z-0834-2022·Announced 2022-04-06

FORE-SIGHT ELITE Tissue Oximeter: Inaccurate Oxygen Saturation Readings

Edwards Lifesciences FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) is recalled because StO2 (tissue oxygen saturation) values may read inaccurately low when used with the large sensor on arms or legs, potentially leading to inappropriate treatment.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device capable of providing inaccurate measurements of a critical vital sign in specific conditions (arms and legs with large sensor), which may lead to inappropriate clinical treatment. No illnesses or injuries are reported in the source material, placing this at the High severity level per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Edwards Lifesciences, LLC is recalling the FORE-SIGHT ELITE Absolute Tissue Oximeter (Model 01-06-3000) because the device may provide inaccurate tissue oxygen saturation (StO2) measurements under specific conditions. When used with the large sensor in certain somatic locations—specifically the arms and legs—the StO2 values may read inaccurately low. Although the directional trend of the readings remains accurate, the magnitude of changes may be larger than expected.

The recall involves 402 units that have been distributed worldwide, including throughout the United States. The device is used clinically to monitor tissue oxygenation levels.

Inaccurately low StO2 readings may lead to unintended or inappropriate treatment decisions based on the device measurements.

Healthcare providers and patients currently using this device should contact Edwards Lifesciences, LLC for instructions. Device model and serial numbers can be verified to confirm whether a specific unit is subject to this recall.

The recalled product

Product
FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
Manufacturer
Edwards Lifesciences, LLC
Category
Medical Device — Tissue Oximeter
Hazard
  • inaccurate-readings
  • measurement-error
  • inappropriate-treatment

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • FORE-SIGHT ELITE Tissue Oximeter
  • Model Number 01-06-3000
  • UDI: 10609538630009
  • All Serial numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category