The Recall Desk

FDA (Devices) recall action 91868

Edwards Lifesciences, LLC recalled 2 products on 2023-04-19

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
2023-04-19
Critical
0
Units
59,420

Why these products were recalled

There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.

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)··2023-04-19

    Swan-Ganz Thermodilution Catheter May Bend and Cause Monitor Error

    Edwards Lifesciences is recalling Swan-Ganz CCOmbo V thermodilution catheters because the distal end may bend beyond its intended curvature, potentially causing the patient monitoring device to display an error message.

    Product
    Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
    Category
    Distribution
    50 states
  • HighFDA (Devices)··2023-04-19

    Thermodilution Catheter May Bend During Use, Causing Monitor Errors

    Edward Lifesciences Swan-Ganz thermodilution catheters may bend during use, potentially causing patient monitoring devices to display error messages. The FDA has recalled 326 affected units distributed nationwide.

    Product
    Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 8.5F (2.8 mm)
    Category
    Distribution
    50 states