Zenith G55192Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002551920), received between Sep 27, 2017 and Jan 30, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 16, 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.

• InjuryJan 30, 2018Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THE ESC-28-12-80-ZT (G55192, LOT: 5365707) GRAFT WAS DEPLOYED OUTSIDE THE PATIENT ¿ INVERTED AND THEN RELOADED BACK INTO THE SHEATH BEFORE INSERTION IN THE PATIENT. THE PATIENT WAS NOT PRESCRIBED ANY ANTICOAGULANTS. THE PATIENT DID NOT HAVE ANY PREDISPOSITION THAT WOULD CAUSE CLOTTING. ADDITIONAL INFORMATION RECEIVED ON 06/18/2018. THE PHYSICIAN ADVISED THAT HE DID NOT PERFORM ANY OTHER TREATMENT ON THE PATIENT. HE SAID THE PATIENT WAS A CLAUDICANT AND HIS ABI¿S WERE THE SAME AS PRE-EVAR SO HE DECIDED AGAINST OFFERING TREATMENT.

  Patient problems: Claudication; Pain

  MAUDE report 7228481 ↗
• MalfunctionNov 15, 2017Leak/Splash; Leak/Splash

  THE AREA REPRESENTATIVE REPORTED THAT DURING PREPARATION FOR AN AORTOILIAC ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE ON A MALE PATIENT, WHEN THE ZENITH WITH Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER WAS FLUSHED, THE FLUID POURED OUT OF THE BACK END OF THE CAPTOR VALVE. WHEN THIS DEVICE WAS INTRODUCED INTO THE PATIENT, BLOOD ALSO STARTED LEAKING FROM THE VALVE. ONCE THE GRAFT WAS DEPLOYED THE DELIVERY SYSTEM WAS REMOVED AND A 20FR SHEATH WAS INSERTED TO REPLACE IT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7035601 ↗
• MalfunctionSep 27, 2017Fluid/Blood Leak; Fluid/Blood Leak

  A ZENITH WITH Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER WAS USED FOR TREATMENT OF AN ILIAC ANEURYSM. IT WAS REPORTED THAT THE HEMOSTATIC VALVE LEAKED TOO MUCH BLOOD. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6898515 ↗