Edwards Lifesciences EZ Glide Aortic Cannula EZF24ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103175066), received between Jul 17, 2024 and Jul 17, 2024 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 ↗

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