Edwards Lifesciences EZ Glide Aortic Cannula EZC24ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103714401), received between Sep 13, 2024 and Apr 18, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

4 other recalls cover devices cleared under the same FDA submission (K123370); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 18, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PLASTIC CONNECTOR OF A EZC24A GOT DETACHED FROM THE CANNULA BODY (TUBE) AFTER DE-AIRING BEFORE TURNING ON THE PUMP. AFTER THE TIP WAS INSERTED TO THE PATIENT'S AORTA, BLOOD FLOW RISING FROM DISTAL TO PROXIMAL CANNULA WAS CONFIRMED, THE CANNULA WAS CLAMPED WITH FORCEPS, AND THEN THE RED CAP WAS REMOVED. AFTER THAT, SALINE WAS INJECTED THROUGH THE CONNECTOR PART OF THE CANNULA, AND TO THE CIRCUIT SIDE TUBING AND THEN THE CONNECTOR AND THE CIRCUIT TUBING WERE CONNECTED. THERE WAS NO BLOOD LEAKAGE FROM THE JUNCTION. THE EZC24A CONNECTOR OR NEAR THE CONNECTOR WAS HELD TO CONNECT TO THE CIRCUIT TUBING. IT WAS NOT COMPRESSED BY THE PHYSICIAN. AFTER DE-AIRING, THE CONNECTOR CAME OFF FROM THE CANNULA BODY THE MOMENT THE PHYSICIAN'S HAND WAS RELEASED. THE PLASTIC CONNECTOR APPEARED TO HAVE A SMOOTH SURFACE WITHOUT ANY SOLVENT APPLIED. INCLUDING THE TIME THAT THE CONNECTOR WAS INSERTED TO THE CIRCUIT TUBING, THERE WAS NO ABNORMALITY NOTED UNTIL THE CONNECTOR COMING OFF. IT WAS HANDLED AS A NORMAL PROCESS AND NO EXTRA FORCE WAS APPLIED WHEN DE-AIRING OR BEFORE THAT. THE CANNULA WAS CHECKED BEFORE USE, BUT NO DAMAGES WERE OBSERVED. AFTER DETACHMENT, ANOTHER CONNECTOR FR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867865 ↗
• MalfunctionOct 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EZC24A FROM LOT NUMBER 425099 WAS OBSERVED TO HAVE A SMALL LEAK DURING THE CASE. THE LEAK PROBABLY ORIGINATED FROM THE BONDED CONNECTOR.

  Patient problems: Insufficient Information

  MAUDE report 20404884 ↗
• MalfunctionSep 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EZC24A (LOT 425099) STARTED TO OOZE AT THE PROXIMAL END, JUST BELOW THE CANNULATION CONNECTION. THIS OCCURRED AS SOON AS THEY WENT ON BYPASS AT THE BEGINNING OF THE PROCEDURE. THE SURGEON USED BONE WAX AND TIES TO TRY AND STOP THE OOZING BUT HAD TO REPLACE THE EZC24A CANNULA WITH ANOTHER OF THE SAME MODEL FROM A DIFFERENT LOT. THEN THE SURGEON WAS ABLE TO FINISH THE CASE SUCCESSFULLY. THE AMOUNT OF BLOOD LOSS DUE TO LEAKAGE IS UNKNOWN. NO PATIENT INJURY REPORTED. NO ABNORMALITIES WERE NOTED AND THERE WAS NO ADDITIONAL PROCESSING OF THE DEVICE PRIOR TO USE. THERE WAS NO PROLONGED COMPRESSION OF THE CANNULA. IT WAS USED DURING AN ASCENDING ARCH CABG CASE. PATIENT INFORMATION NOT PROVIDED. LINE PRESSURE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212513 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123370. One submission often covers many models, so check the product and lot details in each record.

• Z-0420-2020 · Oct 22, 2019 · Terminated
  EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI):
• Z-3027-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
• Z-3028-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
• Z-0134-2014 · Aug 26, 2013 · Terminated
  Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access