Zenith Flex G32183Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002321837), received between Jun 13, 2018 and Jun 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Problem” (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.

• MalfunctionJun 13, 2018Positioning Problem

  IT WAS REPORTED THAT WHILE THE ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION WAS BEING DEPLOYED, THE DEVICE WAS PRESSED AGAINST THE RIGHT SIDE OF THE AORTIC WALL AND ONLY DEPLOYED PROPERLY ON THE LEFT SIDE. THE PHYSICIAN COULD NOT DETERMINE IF THE DEVICE HAD BEEN POSITIONED CORRECTLY BELOW THE LOWEST RENAL ARTERY, SO THEY DECIDED TO REMOVE THE GRAFT, WHICH WAS RE-SHEATHED AND REMOVED SUCCESSFULLY. ANOTHER BACKUP DEVICE WAS PREPARED, BUT THE PHYSICIAN DECIDED TO MAKE A SECOND ATTEMPT AT DEPLOYING THE ORIGINAL GRAFT. WITH SOME DIFFICULTY, THE NEW GRAFT WAS DEPLOYED INTO THE EXISTING ZENITH GRAFT, BUT IT WAS APPROXIMATELY 4-5 MM LOWER THAN INTENDED. THE PHYSICIAN CONTINUED AND IMPLANTED A LIMB EXTENSION. A FINAL DIGITAL SUBTRACTION ANGIOGRAM WAS PERFORMED, SHOWING A SUCCESSFUL RESULT WITH NO TYPE I ENDOLEAKS. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7597271 ↗