Edwards Lifesciences EZ Glide Aortic Cannula EZC21TARecalls & reported problems
Edwards Lifesciences LLC · EZ GLIDE Aortic Cannula · Class 2
All models of Edwards Lifesciences EZ Glide Aortic Cannula (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103174199), received between Aug 19, 2019 and Aug 19, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Disconnection” (1 report).
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
Device problems
- Disconnection1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2019Disconnection
A (B)(6) Y.O. MALE UNDERGOING CARDIAC SURGERY. ~2HRS INTO PROCEDURE, AORTIC CANNULA SUDDENLY DISCONNECTED AT THE PRE-FABRICATED CONNECTION SITE ON THE CANNULA ADJACENT TO CPB TUBING CONNECTION. SURGICAL TEAM IMMEDIATELY CREATED NEW CONNECTION & WAS ABLE TO FILL CANNULA TO AVOID ENTRY OF ANY AIR. PROCEDURE COMPLETED. NO PATIENT HARM OR ADVERSE EFFECT NOTED AT THIS TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8912691 ↗
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 · TerminatedEZ 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 · TerminatedEdwards Lifesciences Aortic Perfusion Cannula, 24F x 30CM, resterilized.
- Z-3028-2018 · Mar 7, 2018 · TerminatedEdwards Lifesciences EZ Glide Aortic Cannula, 24F x 37.6CM, resterilized.
- Z-0134-2014 · Aug 26, 2013 · TerminatedEdwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page