Zenith Flex G55204Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002552040), received between Sep 14, 2020 and Sep 14, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionSep 14, 2020Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THERE WAS DIFFICULTY EXPERIENCED ADVANCING A WIRE GUIDE THROUGH A ZENITH FLEX WITH Z-TRAK AAA ENDOVASCULAR GRAFT MAIN BODY EXTENSION DELIVERY SYSTEM DURING AN ENDOVASCULAR REPAIR OF A FONTAN BAFFLE. THE LUMEN OF THE DEVICE SEEMED TO BE "BLOCKED" AS MULTIPLE COOK AND COMPETITOR WIRE GUIDES WERE UNABLE TO PASS THROUGH THE DEVICE. THE DEVICE WAS TO BE PLACED IN THE PATIENT'S VENOUS SYSTEM. A "MUSTARD PROCEDURE" HAD BEEN PREVIOUSLY COMPLETED. DURING THE REPAIR, THE DEVICE WAS UNABLE TO BE LOADED ONTO THE WIRE AND THEREFOR COULD NOT BE INTRODUCED INTO THE PATIENT. ULTIMATELY, THE INTENDED GRAFT WAS UNABLE TO BE IMPLANTED; IN ITS PLACE, A COMPETITOR BALLOON EXPANDABLE STENT GRAFT WAS SUCCESSFULLY IMPLANTED. IT WAS ALSO REPORTED THAT THE PHYSICIAN WAS AWARE PRIOR TO THE PROCEDURE THAT THE DEVICE WAS BEING USED OFF-LABEL. THE GRAFT WAS NOT ALTERED PRIOR TO IMPLANT. NO ADDITIONAL PROCEDURES WERE NECESSARY AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10530853 ↗