Zenith G55194Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002551944), received between Jul 17, 2017 and Jul 17, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 17, 2017Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH RIGHT AND LEFT FEMORAL ACCESS USING A ZENITH WITH Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER, THE SUTURES OF THE TOP STENT WERE LOOSE AND THAT THE GRAFT WAS SLIDING DOWN THE STENT STRUT. THE EVAR WAS SCHEDULED TO REPAIR ANEURYSM ABOVE PREVIOUS OPEN AORTIC ANEURYSM REPAIR. THE PLAN WAS TO FLIP A CONVERTOR TO SEAL IN OPEN GRAFT IN THE ABDOMINAL AORTA. WE OPENED THE GRAFT ON THE BACK TABLE AND THE PLAN WAS TO FLIP IT AND PUT IT BACK IN THE SHEATH. WHEN WE FIRST OPENED THE FIRST ESC (LOT 5349451), IT SHOWED THAT THE SUTURES OF THE TOP STENT WERE LOOSE AND THAT THE GRAFT WAS SLIDING DOWN THE STENT STRUT (CAPTURED IN MEDWATCH WITH NUMBER 1820334-2017-01510). THE GRAFT WAS THOUGHT TO BE EXPIRING SOON AND PERHAPS THAT WAS THE REASON. ANOTHER GRAFT WAS THEN OPENED THAT WITH AN EXPIRATION DATE IN 2018 (LOT 6264283) AND THE SAME PROBLEM OCCURRED (CAPTURED IN MEDWATCH WITH NUMBER 1820334-2017-01511). THE DOCTOR DECIDED TO ADD SUTURES TO FIX THE PROBLEM BEFORE PUTTING IT BACK IN THE SHEATH. ISSUE WAS THAT THE LOOSE SUTURES AFFECTED THE SEAL STENT AND THEREFORE AFFECTED SEAL ZONE BY DECREASING THE ACCURACY OF THE SEAL. THE PATI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6717088 ↗
• MalfunctionJul 17, 2017Defective Device; Defective Device

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) WITH RIGHT AND LEFT FEMORAL ACCESS USING A ZENITH WITH Z-TRAK AAA ENDOVASCULAR GRAFT CONVERTER, THE SUTURES OF THE TOP STENT WERE LOOSE AND THAT THE GRAFT WAS SLIDING DOWN THE STENT STRUT. THE EVAR WAS SCHEDULED TO REPAIR ANEURYSM ABOVE PREVIOUS OPEN AORTIC ANEURYSM REPAIR. THE PLAN WAS TO FLIP A CONVERTOR TO SEAL IN OPEN GRAFT IN THE ABDOMINAL AORTA. WE OPENED THE GRAFT ON THE BACK TABLE AND THE PLAN WAS TO FLIP IT AND PUT IT BACK IN THE SHEATH. WHEN WE FIRST OPENED THE FIRST ESC (LOT 5349451), IT SHOWED THAT THE SUTURES OF THE TOP STENT WERE LOOSE AND THAT THE GRAFT WAS SLIDING DOWN THE STENT STRUT (CAPTURED IN MEDWATCH WITH NUMBER 1820334-2017-01510). THE GRAFT WAS THOUGHT TO BE EXPIRING SOON AND PERHAPS THAT WAS THE REASON. ANOTHER GRAFT WAS THEN OPENED THAT WITH AN EXPIRATION DATE IN 2018 (LOT 6264283) AND THE SAME PROBLEM OCCURRED (CAPTURED IN MEDWATCH WITH NUMBER 1820334-2017-01511). THE DOCTOR DECIDED TO ADD SUTURES TO FIX THE PROBLEM BEFORE PUTTING IT BACK IN THE SHEATH. ISSUE WAS THAT THE LOOSE SUTURES AFFECTED THE SEAL STENT AND THEREFORE AFFECTED SEAL ZONE BY DECREASING THE ACCURACY OF THE SEAL. THE PATI

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6717065 ↗