Fem-Flex II Femoral Arterial Cannula FEMII016ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103031232), received between Dec 22, 2025 and Jan 20, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

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-2082-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2026

  PATIENT HAD BILATERAL LUNG TRANSPLANT AND REQUIRED VV ECMO [VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION]. AROUND 12 HOURS LATER, THE CANULA WAS FOUND TO BE CRACKED AND THE PATIENT NEEDED TO GO BACK TO THE OR FOR EXCHANGE LEADING TO A CARDIAC ARREST AND CONVERSION TO CENTRAL ECMO.

  Patient problems: Cardiac Arrest

  MAUDE report 24114649 ↗
• InjuryDec 22, 2025Mechanical Problem; Mechanical Problem

  EDWARDS RECEIVED A REPORT OF AN EDWARDS FEMII016A CANNULA THAT WAS FOUND TO BE LEAKING DURING USE. THE CANNULA WAS INSERTED AFTER A LUNG TRANSPLANT FOR V-V ECMO INITIATION. BLEEDING FROM THE CANNULA WAS NOTED THE NEXT DAY. THIS LED TO AN EXCHANGE OF CANNULA AND BLOOD LOSS FOR THE PATIENT. THE ESTIMATED TIME THE DEVICE WAS IN USE WAS 27 HOURS (21 HOURS PAST THE 6 HOURS IN THE IFU). THEY ALSO NOTED THEY HAD TO BRING THE PATIENT BACK TO THE OR THE NEXT DAY. IT APPEARS THERE WAS A CRACK/ FRACTURE IN THE LINE, AND BLOOD WAS COMING OUT OF THE LINE. THE CANNULA WAS PLACED, AND THE CRACK WAS NOT FOUND UNTIL A LATER TIME AFTER THE PACKAGING WAS DISPOSED OF. THEREFORE, THE LOT NUMBER IS UNKNOWN. THE CANNULA IS BEING HELD BY RISK MANAGEMENT AND THE INVESTIGATIVE LEAD HAS CONFIRMED NO FURTHER INFORMATION WILL BE SHARED OUTSIDE OF AN OFFICIAL LEGAL REQUEST. DEVICE NOT RETURNED. NO IMAGES PROVIDED. WHEN ASKED ABOUT THE TECHNIQUE USED FOR PLACEMENT/ SET UP FOR ECMO, THE PERFUSION DIRECTOR PROVIDED THE FOLLOWING: VV ECMO - DRAINAGE 23FR BIOMEDICUS FEM VEIN, REINFUSION - 16F FEM FLEX LEFT SUBCLAVIAN VEIN. THEY ALSO STATED THAT THE CANNULA WAS NOT AT AN ANGLE/ CURVED DURING USE. THE DEVICE WAS INSER

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23871998 ↗

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-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