Zenith G29889Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002298894), received between May 14, 2015 and May 14, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2015Leak/Splash

  THIS (B)(6) MALE PATIENT IN THE SPIRAL-Z POST-MARKET REGISTRY ((B)(4)) HAD A TYPE III ENDOLEAK AT THE CONCLUSION OF THE DEPLOYMENT PROCEDURE ON (B)(6) 2015. THE PATIENT WAS BEING TREATED FOR AN AORTOILIAC ANEURYSM WITH A MAXIMUM AORTIC ANEURYSM DIAMETER OF 31 MM. THE PROXIMAL NECK HAD A PARALLEL SHAPE WITH NO PLAQUE/THROMBUS. THE LEFT ILIAC ARTERY HAD MILD TORTUOSITY, MILD CALCIFICATION, AND MILD OCCLUSIVE DISEASE. THE RIGHT ILIAC ARTERY HAD MODERATE TORTUOSITY, MILD CALCIFICATION, AND MILD OCCLUSIVE DISEASE. THE PATIENT RECEIVED A COOK PROXIMAL 26 MM X 74 MM MAIN BODY DEVICE, A 13 MM X 90 MM LEFT ILIAC LEG DEVICE, A 13 MM X 74 MM RIGHT ILIAC LEG DEVICE, A 16 MM X 90 MM LEFT ILIAC LEG EXTENSION AND A 16 MM X 74 MM RIGHT ILIAC LEG EXTENSION. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. A MOLDING BALLOON WAS USED BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AFTER THE PROCEDURE, ONE COVERED ILIAC ARTERY STENT WAS PLACED IN THE LEG/LEG EXTENSION IN THE LEFT ILIAC. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, OR THROMBUS. A TYPE III ENDOLEAK WAS NOTED. THE SUBTYPE OF THE TYPE III WAS NOTED AS GRAFT OVERLAP

  Patient problems: Other (for use when an appropriate patient code cannot be identified)

  MAUDE report 4780361 ↗