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Edwards Lifesciences Femoral Venous Cannula VFEM022Recalls & reported problems

Edwards Lifesciences LLC · Femoral Venous Cannula · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103146660), received between Nov 1, 2021 and Nov 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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

Device problems

  • Packaging Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionNov 1, 2021Packaging Problem; Packaging Problem

    EDWARDS WAS NOTIFIED THAT THREE CANNULAS WERE RECEIVED IN WET CARTONS WITH SIGNS OF MOISTURE INSIDE THE STERILE PACKAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12729723 ↗

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-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-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-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-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-3032-2018 · Mar 7, 2018 · Terminated
    Edwards Lifesciences Femoral Venous Cannula, 18FR, resterilized.
  • Z-3033-2018 · Mar 7, 2018 · Terminated
    Edwards Lifesciences Femoral Venous Cannula, 20F X 55CM, 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

Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices

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Sources and updates

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