Edwards Lifesciences Femoral Venous Cannula VFEM018Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103146646), received between Apr 11, 2023 and Apr 11, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

7 other recalls cover devices cleared under the same FDA submission (K140208, K200358); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2023Fluid/Blood Leak; Fluid/Blood Leak

  EDWARDS RECEIVED INFORMATION A VENOUS FEMII (MODEL NUMBER UNKNOWN) WAS LEAKING. IT WAS REPORTED THE PATIENT WAS TAKEN BACK TO THE OR NEXT DAY FOR CANNULA CHANGE. PATIENT REQUIRED MULTIPLE TRANSFUSIONS. THE FLUID LEAKING WHERE THE TWO CONNECTIONS ARE FUSED MOLDING LEAK. DEVICE IS NOT AVAILABLE.

  Patient problems: Exsanguination

  MAUDE report 16713519 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K140208, K200358. One submission often covers many models, so check the product and lot details in each record.

• Z-2083-2025 · May 14, 2025 · Open, Classified
  Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion C
• Z-2084-2025 · May 14, 2025 · Open, Classified
  Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Ca
• Z-2082-2025 · May 14, 2025 · Open, Classified
  Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Ca
• Z-2085-2025 · May 14, 2025 · Open, Classified
  Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion C
• Z-3033-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, resterilized.
• Z-3032-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
• Z-1371-2015 · Mar 23, 2015 · Terminated
  Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII0