Edwards Lifesciences EZ Glide Aortic CannulaRecalls & reported problems across all models

We found 7 models of Edwards Lifesciences EZ Glide Aortic Cannula by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 23 adverse event reports in the FDA's MAUDE database, received between Aug 19, 2019 and Jul 15, 2026 — classified as 6 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 reports).

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

Most reported Edwards Lifesciences EZ Glide Aortic Cannula problems

Edwards Lifesciences EZ Glide Aortic Cannula models

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

• Edwards Lifesciences EZ Glide Aortic Cannula EZF21A

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  8 reports
• Edwards Lifesciences EZ Glide Aortic Cannula EZC21A

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  4 reports
• Edwards Lifesciences EZ Glide Aortic Cannula EZS21TA

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  3 reports
• Edwards Lifesciences EZ Glide Aortic Cannula EZC24A

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  3 reports
• Edwards Lifesciences EZ Glide Aortic Cannula EZC24TA

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  3 reports
• Edwards Lifesciences EZ Glide Aortic Cannula EZC21TA

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report
• Edwards Lifesciences EZ Glide Aortic Cannula EZF24A

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

Recent Edwards Lifesciences EZ Glide Aortic Cannula adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Material Integrity Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25821838 ↗
• 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 ↗
• MalfunctionNov 21, 2024Crack; Crack

  IT WAS REPORTED THAT A CRACK WAS NOTED ON THE UPPER PART OF AN EZC21A (LOT 423540) CANNULA DURING AN OPEN-HEART SURGERY. THE DEVICE WAS INSPECTED PRIOR TO USE. IT WAS REPORTED THAT THERE IS A POTENTIAL FOR PATIENT HARM TO HAVE OCCURRED DUE TO THIS FAILURE AS AIR MIGHT HAVE ENTERED INTO THE BLOOD STREAM THROUGH THE COMPROMISED CANNULA CAUSING NEUROLOGICAL DAMAGE TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT KNOWN INCIDENT; HOWEVER, FEAR WAS NEUROLOGICAL DAMAGE AND HENCE THE EFFECTS WILL NOT BE KNOWN UNTIL LATER. THE CURRENT STATUS OF THE PATIENT IS NOT KNOWN AT PRESENT. THERE WAS NO CHANGE IN THE PROCEDURAL STRATEGY DUE TO THE EVENT. DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: Insufficient Information

  MAUDE report 20751617 ↗
• MalfunctionOct 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  AS REPORTED BY OUR EDWARDS LIFESCIENCES JAPANESE AFFILIATE THERE WAS BLOOD LEAKAGE OBSERVED AT THE CONNECTION BETWEEN THE CONNECTOR AND THE EZC21A CANNULA TUBE AFTER THE PUMP WAS INITIATED DURING USE. SPECIFIC TIMING AFTER THE PUMP INITIATION WAS UNKNOWN. THE LEAKAGE WAS ABOUT 1 DRIP IN 5 TO 10 SECONDS. THE DEVICE WAS KEPT USING. THERE WAS NO IMPACT TO THE OVERALL OUTCOME OF THE PROCEDURE. THE SURGEON DID NOT CONSIDER THE INCIDENT A SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO CHANGE IN PROCEDURAL STRATEGY REQUIRED DUE TO THE LEAKAGE. THE PATIENT STATUS WAS REPORTED AS 'RECOVERING'. THE DEVICE WAS USED FOR PEDIATRIC HEART SURGERY. PER THE REPORT, NO ABNORMALITIES IN APPEARANCE WERE OBSERVED BEFORE OR AFTER USE. THE CANNULA WAS CONNECTED TO THE CPB TUBING AS ALWAYS. STRONG FORCE WAS NOT NECESSARY TO CONNECT THEM.

  Patient problems: Insufficient Information

  MAUDE report 20533920 ↗
• MalfunctionOct 14, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EZC21A OF LOT 423540 WAS NOTED TO BE LEAKING DURING A CASE. THE LEAK WAS NOTED BETWEEN THE DEVICE CONNECTOR AND THE MAIN BODY AND LIKELY OCCURRED AFTER BYPASS WAS INITIATED. IT WAS NOTICED JUST PRIOR TO TERMINATING CPB WHEN THE TOWEL COVERING THE CANNULA WAS REMOVED. NO ABNORMALITIES WERE NOTED DURING PREPARATION OF THE DEVICE. THERE WAS NO REPORTED DIFFICULTY IN CONNECTING THE CANNULA TO THE CIRCUIT TUBING AND NO PROLONGED FORCE/COMPRESSION WAS APPLIED ON THE CANNULA. PATIENT BLOOD VOLUME WAS USED TO DE-AIR THE CANNULA AND THERE WAS NO DIFFICULTY IN DE-AIRING. THE OUTCOME OF THE PROCEDURE WAS REPORTED TO BE NORMAL AND THERE IS NO KNOWN IMPACT ON THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE AND THE DEVICE WAS NOT EXCHANGED FOR ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20446783 ↗
• 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 ↗
• 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 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 ↗
• MalfunctionSep 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN EZC21A FROM LOT 419860 LEAKED DURING USE 45 MINUTES INTO A CABG PROCEDURE. THE PRODUCT LEAKED AT THE BOND SECTION OF CANNULA TO CONNECTOR. THE DEVICE WAS REPORTED TO BE USED PER EDWARDS' INSTRUCTION FOR USE. REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT OR "NO ADVERSE EFFECTS". BLOOD LOSS WAS MINIMAL IN THAT IT WAS NOT MEASURABLE. THE UNIT WAS STORED IN STERILE STORAGE "PUMP ROOM" UNDER TEMPERATURE AND HUMIDITY CONTROLLED CONDITIONS. NO ABNORMALITIES, ADDITIONAL TREATMENT OR ADDITIONAL PROCESSING PRIOR TO USE. NO DIFFICULTY IN CONNECTING CANNULA TO THE CIRCUIT TUBING. THE TRADITIONAL BACK BLEEDING OF THE CANNULA AFTER INSERTION IN THE AORTA WAS USED TO DEAIR THE CANNULA. THE DEVICE WAS NOT EXPOSED TO ANY PROLONGED FORCE OR COMPRESSION. BYPASS WAS INITIATED PRIOR TO LEAKAGE - THE DURATION OF THE BYPASS RUN WAS 84 MINUTES. NO CABLE TIE WAS USED AT THE LEAKAGE SITE BECAUSE IT WAS A FACTORY BONDED CONNECTION. THE PERFUSIONIST CLARIFIED THAT THEY DID NOT RECANNULATE/ THAT THE DEVICE WAS NOT REPLACED AS BLOOD LOSS WAS MINIMAL AND A STERILE TOWEL WAS PLACED UNDER THE CANNULA TO CONTAIN LEAKAGE. PATIENT WAS FEMALE AND WEIGHT WAS REPORTED AS 75.5 KG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20208511 ↗
• 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 17, 2024

  AORTIC CANNULA APPEARED TO HAVE EXPERIENCED A COLOR CHANGE, THIS WAS NOTICED AFTER TERMINATION OF BYPASS. THE BYPASS RUN IN QUESTION WAS LENGTHY, PERHAPS THIS CONTRIBUTED TO THE WITNESSED EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19761046 ↗
• 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 ↗

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