Fem-Flex II Femoral Arterial CannulaRecalls & reported problems across all models

We found 3 models of Fem-Flex II Femoral Arterial Cannula by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Sep 28, 2021 and Jan 20, 2026 — classified as 3 injuries.

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

2 FDA recall records name at least one of these models by its device identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Fem-Flex II Femoral Arterial Cannula recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 ↗

2. 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 Fem-Flex II Femoral Arterial Cannula problems

Fem-Flex II Femoral Arterial Cannula models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Fem-Flex II Femoral Arterial Cannula FEMII016A

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall2 reports
• Fem-Flex II Femoral Arterial Cannula FEMII018AS

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 recall0 reports
• Fem-Flex II Femoral Arterial Cannula FEMII020A

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report

Recent Fem-Flex II Femoral Arterial Cannula adverse event reports

The 3 most recent reports across all models, 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 ↗
• 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 ↗

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