Edwards Lifesciences EZ Glide Aortic Cannula EZC21ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00690103174182), received between Sep 12, 2024 and Nov 21, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗

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-3028-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
• Z-3027-2018 · Mar 7, 2018 · Terminated
  Edwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, 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