Edwards Lifesciences EZ Glide Aortic Cannula EZF21ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00690103175080), received between Mar 4, 2024 and Oct 3, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY OUR EDWARDS LIFESCIENCES JAPANESE AFFILIATE, SOLUTION (BLOOD AND FLUID IN THE CPB RESERVOIR) LEAKAGE WAS OBSERVED AT THE CONNECTION BETWEEN THE CONNECTOR AND THE EZF21A CANNULA TUBE RIGHT AFTER THE DEVICE WAS INSERTED TO THE PATIENT AND THE CARDIOPULMONARY BYPASS WAS INITIATED. THE SOLUTION WAS DRIPPING. THE DEVICE WAS REPLACED. THE SURGEON THINKS THAT THE DEVICE WAS NOT GLUED CORRECTLY. THE PATIENT STATUS WAS REPORTED AS 'RECOVERED'. CONNECTING THE CANNULA TO THE CPB TUBING WAS NOT DIFFICULT. THE CANNULA WAS STORED FLAT AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20357397 ↗
• MalfunctionSep 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY OUR EDWARDS LIFESCIENCES JAPANESE AFFILIATE, BLOOD LEAKED FROM THE CONNECTOR PART OF AN EZF21A AORTIC CANNULA AFTER INITIATION OF CARDIOPULMONARY BYPASS (CPB). THE AMOUNT OF BLOOD LEAKAGE WAS SMALL, SO THE CUSTOMER DETERMINED THAT THERE WAS NO RISK TO THE PATIENT AND CONTINUED TO USE THE CANNULA WITHOUT REPLACING IT. THERE WAS NO PATIENT ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20321825 ↗
• MalfunctionSep 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY OUR EDWARDS LIFESCIENCES JAPANESE AFFILIATE, BLOOD LEAKED FROM AN EZF21A AORTIC CANNULA AFTER INITIATION OF CARDIOPULMONARY BYPASS (CPB). THE LEAKAGE OCCURRED FORM THE CONNECTION BETWEEN THE CANNULA BODY AND THE CONNECTOR. THE CUSTOMER ADDRESSED THE LEAKAGE WITH A STERILE TIE-BAND AND CONTINUED TO USE THE CANNULA WITHOUT REPLACING IT. AMOUNT OF THE BLOOD LOSS WAS NOT PROVIDED. OTHER THAN ADDRESSING THE LEAKAGE WITH TIE-BAND, THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE, AND THERE WAS NO PATIENT ADVERSE EVENT REPORTED. THE PATIENT STATUS WAS NOT PROVIDED. PER THE REPORTED INFORMATION, THE DEVICE WAS USED FOR AN AORTIC VALVE REPLACEMENT. THE DEVICE WAS PREPARED AND CONNECTED TO THE TUBING OF CPB AS PER THE IFU WITHOUT ANY PROBLEMS. DE-AIRING WAS PERFORMED AS USUAL AND THERE WAS NO PROBLEM OBSERVED. THE DEVICE WAS STORED HORIZONTALLY ON THE SHELF AT THE HOSPITAL PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20298890 ↗
• MalfunctionSep 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD LEAKAGE STARTED TO BE OBSERVED AT THE CONNECTION BETWEEN THE CONNECTOR AND THE EZF21A CANNULA TUBE AFTER CARDIOPULMONARY BYPASS WAS INITIATED, LIKE WHEN THE AORTA WAS CLAMPED. THE LEAKAGE WAS SEEN ABOUT ONE DROP PER 30 SECONDS. THE TOTAL CANNULATION TIME WAS ABOUT TWO 2 HOURS AND 32 MINUTES, THEREFORE THE VOLUME OF BLOOD LOSS IS ESTIMATED TO BE ABOUT 100 CC. THE AMOUNT OF BLOOD LEAKAGE WAS SMALL, THE CANNULA WAS KEPT USING WITHOUT FASTENING THE SITE. NO ABNORMALITY WAS NOTED BEFORE OR AFTER THE DEVICE USE. TUBING WAS NOT CLAMPED NEAR ANY BONDED PORTIONS OF THE CANNULA. THERE WAS NO SIGNIFICANT DELAY IN PROCEDURE, IMPACT TO THE OVERALL OUTCOME OF THE PROCEDURE, NOR CHANGE IN PROCEDURE. THE SURGEON THINKS THAT THERE WAS A DEVICE MALFUNCTION. THE PATIENT STATUS WAS REPORTED AS 'RECOVERED'. THE CANNULA WAS USED FOR AORTIC VALVE REPLACEMENT. CONNECTING THE CANNULA TO THE CPB TUBING WAS NOT DIFFICULT. THE CANNULA WAS DEAIRED BY FILLING THE CANNULA BY THE PATIENT BLOOD WITHIN THE CPB TUBING. THERE WAS NO DIFFICULTY DEHAIRING. THE TOTAL CPB TIME WAS 140 MINUTES. THE CANNULA WAS STORED FLAT AT THE HOSPITAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20131490 ↗
• MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY EDWARDS LIFESCIENCES AFFILIATION THROUGH OUR JAPANESE POST-MARKETING SURVEILLANCE SYSTEM, EDWARDS RECEIVED INFORMATION THAT BLOOD LEAKAGE OCCURRED FROM THE CONNECTOR OF AN EZF21A AORTIC CANNULA DURING USE. THE CUSTOMER WAS NOT SURE WHEN THE LEAKAGE OCCURRED, BUT THEY BECAME AWARE OF THE LEAKAGE FROM THE CONNECTOR WHEN THEY NOTICED BLOOD DRIPPING ON THE FLOOR JUST BEFORE THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS (CPB). DEFINITE DURATION OF THE CANNULA USE WAS NOT REPORTED BUT WAS REPORTED ROUGHLY 120-180 MINUTES. THE EXACT AMOUNT OF BLOOD LOSS WAS UNKNOWN, BUT THIS LEAKAGE WAS REPORTED TO HAVE NO IMPACT ON THE PATIENT DURING PROCEDURE. BECAUSE THIS EVENT WAS FOUND WHEN THE PATIENT WAS ABOUT TO BE WEANED FROM CPB, THE CANNULA WAS USED WITHOUT REPLACEMENT AND ONLY GAUZE WAS APPLIED TO THE CONNECTOR RATHER THAN A ZIP TIE TO ADDRESS THE LEAKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THE PATIENT OUTCOME WAS REPORTED AS 'UNDER TREATMENT'. THE CANNULA WAS USED IN AN AORTIC VALVE REPLACEMENT PROCEDURE. PER THE CUSTOMER, THE BLOOD LEAK APPEARED TO BE OOZING FROM THE CONNECTOR AREA, BUT THEY DID NOT KNOW WHERE EXACTLY THE LEAK WAS COMING FROM. THEY ALSO COMMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19833889 ↗
• MalfunctionJul 1, 2024Break; Break

  IT WAS REPORTED THAT THE SUTURE FLANGE OF THE EZF21A CANNULA WAS FOUND CHIPPED OR DEFORMED AFTER CANNULATION TO THE ASCENDING AORTA DURING USE. DUE TO THE DAMAGE, THE POSITION OF THE CANNULA GOT SHIFTED DURING SURGERY AND REQUIRED TO FIX IT. IT LED TO EXTENSION OF OPERATIVE TIME. THE CANNULA WAS ORIGINALLY USED FOR LEFT VENTRICULAR TUMOR REMOVAL SURGERY. WHEN FINISHED AFTER RELEASING THE CANNULA CLAMP, MITRAL REGURGITATION APPEARED. WITHOUT EXCHANGING THE CANNULA, IT WAS CLAMPED AGAIN, AND CARDIO-PULMONARY BYPASS WAS STARTED FOR MITRAL VALVE REPLACEMENT. THE CANNULA POSITION WAS SHIFTED THEN. IT IS UNKNOWN HOW LONG IN TOTAL THE CANNULA WAS USED. THE DEFORMATION/DAMAGE OF THE FLANGE WAS NOT NOTICED UNTIL CANNULATION. THE CANNULA WAS NOT CHECKED PRIOR TO USE. THE CANNULA WAS NOT REPLACED BECAUSE THERE WAS A RISK OF PERFUSION BLOOD LOSS AND EXTENSION OF OPERATIVE TIME. THE FRAGMENT OF THE CHIPPED FLANGE WAS NOT FOUND. THE SURGEON COMMENTED THAT THE CROSS SECTION OF THE FLANGE APPEARED VERY SMOOTH- IF IT IS CHIPPED, IT WOULD APPEAR TO BE ROUGHER. HE WOULD LIKE TO KNOW IF IT WAS DEFORMED OR CHIPPED. THE SURGEON ALSO COMMENTED THAT THE CANNULA POSITION WOULD NOT HAVE SHIFTED WHEN THE FLA

  Patient problems: Insufficient Information

  MAUDE report 19651333 ↗
• MalfunctionJun 28, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BLOOD WAS DRIPPING FROM THE CONNECTOR NEAR THE CANNULA BODY OF EZF21A CANNULA AFTER CARDIOPULMONARY BYPASS WAS INITIATED. THE SPECIFIC VOLUME OF BLOOD LOSS IS UNKNOWN. THE SITE WAS FASTENED WITH A CABLE TIE GUN TO STOP THE LEAKAGE AND THE CANNULA WAS KEPT USING. NO ABNORMALITY WAS NOTED BEFORE OR AFTER THE DEVICE USE. EXCESSIVE FORCE WAS NOT REQUIRED TO CONNECT THE CANNULA. THE SURGEON COMMENTED IT WAS A SIGNIFICANT DELAY IN PROCEDURE BECAUSE IT TOOK TIME TO DETECT WHERE THE BLOOD LEAKAGE WAS COMING FROM AND AFTER THE SITE WAS FASTENED WITH A CABLE TIE GUN, THE SITE REQUIRED TO CHECK CONSTANTLY WITHOUT BLOOD LEAKAGE. IT IS UNKNOWN HOW LONG IN TOTAL THE CANULA WAS USED AND HOW LONG THE CANNULA WAS IN USE PRIOR TO THE LEAKAGE. THERE WAS NO IMPACT TO THE OVERALL OUTCOME OF THE PROCEDURE. THE PATIENT STATUS WAS REPORTED AS 'RECOVERED'. THE CANNULA WAS USED FOR CORONARY ARTERY BYPASS GRAFT. CONNECTING THE CANNULA TO THE CPB TUBING WAS NOT DIFFICULT. THE CANNULA WAS STORED FLAT AT THE HOSPITAL. THE DEVICE WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19634835 ↗
• MalfunctionMar 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SMALL AMOUNT OF BLOOD LEAKAGE BETWEEN THE CONNECTOR AND THE EZF21A CANNULA BODY WAS NOTED ABOUT TEN (10) MINUTES AFTER THE AORTIC BLOCKAGE DURING SURGERY. THE BLOOD WAS DRIPPING. THE SITE WAS TIED UP WITH A THREAD TO STOP THE LEAKAGE AND IT STOPPED. AFTER THAT, THE SURGEON KEPT USING THE CANNULA. THE PATIENT STATUS WAS REPORTED AS RECOVERED. THERE WAS NO VISUAL ABNORMALITY NOTED BEFORE AND AFTER USE ON THE CANNULA. THE SURGEON COMMENTED THAT THE BLACK THREAD TO STOP THE LEAKAGE REMAINED ATTACHED TO THE RETURNED CANNULA. THE SURGEON SUSPECTED IT IS A BONDING RELATED MALFUNCTION. IT IS UNKNOWN HOW LONG IN TOTAL THE CANULA WAS USED. THERE WAS NO IMPACT TO THE OVERALL OUTCOME OF THE PROCEDURE. THERE WAS NO SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO CHANGE IN PROCEDURAL STRATEGY REQUIRED DUE TO THE LEAKAGE. THE CANNULA WAS STORED FLAT AT THE HOSPITAL. THE CANNULA WAS USED FOR MITRAL VALVULOPLASTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832539 ↗

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