Fem-Flex II Femoral Arterial Cannula FEMII020ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103031287), received between Sep 28, 2021 and Sep 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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.

• InjurySep 28, 2021Fracture; Fracture

  IT WAS REPORTED THAT THE FEMII020A CANNULA SNAPPED/BROKE AFTER THREE DAYS AFTER THE INITIAL PLACEMENT. ADDITIONAL INFORMATION RECEIVED: THE PATIENT WAS ABOUT TO BE PREPPED AND DRAPED HOWEVER WE NOTICED SIGNIFICANT BLEEDING FROM THE RIGHT IJ CANNULA, WE NOTICED THAT THE CANNULA WAS CRACKED AS A RESULT WE QUICKLY STOPPED THE ECMO AND CLAMPED THAT CANNULA AND THIS WAS FOLLOWED BY SWITCHING THE CONFIGURATION OF VV ECMO TO A FEM FEM VV ECMO AND REMOVED THE RIGHT IJ FEMFLEX CANNULA. THE PRESSURE WAS HELD AND NO HEMATOMA DEVELOPED. THE CANNULA WAS REMOVED AND REPLACED WITH A 32 F MC3 CANNULA PLACED IN LEFT IJ. ON POD #4, THE PATIENT EXPIRED. THE PATIENT'S DEATH WAS NOT RELATED TO THE CATHETER.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12541219 ↗

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-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-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-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