Zenith Flex G42783Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002427836), received between May 1, 2020 and May 1, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult 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.

• MalfunctionMay 1, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM OF A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION DURING A PROCEDURE. THE PROCEDURE IN QUESTION WAS TO TREAT A "COMPLICATED" ABDOMINAL AORTIC ANEURYSM IN A (B)(6) YEAR OLD FEMALE PATIENT. AFTER THE INITIAL MEASUREMENTS AND ANGIOGRAPHY, A COMPETITOR'S STENT WAS CHOSEN FOR IMPLANTATION DUE TO ITS "ELASTICITY" AND WAS SUCCESSFULLY DEPLOYED. THE PATIENT REPORTEDLY HAD SEVERE TORTUOSITY IN THE "TUMOR NECK", SO A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION WAS USED TO EXPAND THE ANCHORING ZONE. THE DEVICE WAS INTRODUCED IN THE LEFT FEMORAL ARTERY, BUT COULDN'T BE ADVANCED THROUGH THE "TUMOR NECK" TO THE TARGET POSITION EVEN AFTER MULTIPLE ATTEMPTS. THE DELIVERY SYSTEM WAS WITHDRAWN AND WAS OBSERVED TO BE BENT NEAR THE "SHEATH DILATOR TIP" UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S STENT. NO SHEATH DAMAGE WAS NOTED PRIOR TO USE. THE PATIENT RECOVERED WELL AFTER THE PROCEDURE. NO ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10017756 ↗