The Recall Desk

FDA (Devices) recall action 90905

Edwards Lifesciences, LLC recalled 2 products on 2022-11-09

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
2022-11-09
Critical
0
Units
742,180

Why these products were recalled

Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.

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)··2022-11-09

    Fogarty Arterial Embolectomy Catheters Recalled for Latex Deterioration

    Edwards Lifesciences is recalling 715,620 Fogarty Arterial Embolectomy Catheters due to confirmed latex deterioration in the pouch packaging. The material degradation could affect device performance during use.

    Product
    Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP
    Category
    Distribution
    52 states
  • HighFDA (Devices)··2022-11-09

    Fogarty Biliary Balloon Probes recalled for latex deterioration

    Edwards Lifesciences is recalling Fogarty Biliary Balloon Probes due to confirmed latex deterioration in pouches. The recall affects 26,560 units distributed worldwide.

    Product
    Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
    Category
    Distribution
    52 states