Edwards Lifesciences EZ Glide Aortic Cannula EZC24TARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103714418), received between Jul 8, 2022 and Jul 13, 2022 — classified as 3 injuries.

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

• InjuryJul 13, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE VENTED CONNECTOR OF A EZC24TA EZ GLIDE AORTIC CANNULA SEPARATED FROM THE CANNULA. THERE WERE NO PATIENT INJURIES. PER REP THIS WAS A CABG PROCEDURE AND THE EVENT OCCURRED TOWARDS THE END OF THE PROCEDURE. NO EXCHANGE OF CANNULA WAS REQUIRED. NO ABNORMALITY OF THE DEVICE OR PACKAGING WAS NOTED PRIOR TO USE. PER THE PERFUSIONIST THE IT CAME LOOSE AT THE RED-CAP. IT HAS TO DEAL WITH THE BONDED VENT CONNECTOR SITE. THE PERFUSIONIST FEELS THE ISSUE LIES WITHIN THE SMALL VENT CONNECTOR BARB AND RECOMMENDS A THREE BARB CONNECTOR.

  Patient problems: Insufficient Information

  MAUDE report 15000396 ↗
• InjuryJul 8, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE VENTED CONNECTOR OF AN EZ GLIDE AORTIC CANNULA CAME LOOSE. THERE WERE NO PATIENT INJURIES. PER REP THIS WAS A CABG PROCEDURE AND THE EVENT OCCURRED TOWARDS THE END OF THE PROCEDURE. NO EXCHANGE OF CANNULA WAS REQUIRED. NO ABNORMALITY OF THE DEVICE OR PACKAGING WAS NOTED PRIOR TO USE.

  Patient problems: Insufficient Information

  MAUDE report 14959268 ↗
• InjuryJul 8, 2022Nonstandard Device; Nonstandard Device

  IT WAS REPORTED THAT THE VENTED CONNECTOR OF A EZ GLIDE AORTIC CANNULA CAME LOOSE AND THE DISTAL TIP HAD A CRACK. THERE WERE NO PATIENT INJURIES. PER REP THIS WAS A CABG PROCEDURE AND THE EVENT OCCURRED TOWARDS THE END OF THE PROCEDURE. NO EXCHANGE OF CANNULA WAS REQUIRED. NO ABNORMALITY OF THE DEVICE OR PACKAGING WAS NOTED PRIOR TO USE.

  Patient problems: Insufficient Information

  MAUDE report 14959177 ↗

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