Skip to content

Fem-Flex II Femoral Arterial Cannula FEMII018ASRecalls & reported problems

Edwards Lifesciences LLC · FEM-FLEX II Femoral Arterial Cannula · Class 2

All models of Fem-Flex II Femoral Arterial Cannula (3)

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

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

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

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

6 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.

Recalls naming this device

  1. May 14, 2025Class IOpen, Classified

    due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

    Z-2085-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

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-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-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-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

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

All CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page