The Recall Desk

FDA (Devices) recall action 89647

Edwards Lifesciences, LLC recalled 2 products on 2022-04-06

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-04-06
Critical
0
Units
8,791

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··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.

    Product
    FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA.
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2022-04-06

    Tissue oximeter module may provide inaccurately low oxygen readings

    Edwards Lifesciences is recalling 8,389 FORE-SIGHT ELITE Tissue Oximeter modules that may display inaccurately low oxygen saturation values when used in certain body locations, potentially leading to inappropriate treatment decisions.

    Product
    FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
    Category
    Distribution
    50 states