Zenith Flex G48434Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002484341), received between Jun 14, 2018 and Feb 7, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2019Activation Problem; Activation Problem

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318175 ↗
• InjuryJun 14, 2018Occlusion Within Device; Occlusion Within Device

  ON (B)(6) 2018, THE PATIENT HAD AN INITIAL ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THREE DEVICES WERE IMPLANTED INCLUDING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS. AT THE END OF THE INITIAL PROCEDURE THE GRAFTS WERE WIDE OPEN, PATENT AND HAD NO KINKS. ON (B)(6) 2018, ONE WEEK AFTER THE IMPLANT, THE PATIENT CAME TO THE HOSPITAL PRESENTING WITH ONSET OF BILATERAL LOWER EXTREMITY PAIN, NUMBNESS AND MOTOR LOSS. IT WAS THEN DETERMINED THAT THE ENTIRE GRAFT SYSTEM HAD THROMBOSED. THE DIAGNOSIS WAS, AORTIC THROMBOSIS OF BILATERAL LOWER EXTREMITIES AND ACUTE LIMB THROMBOSIS. THE PHYSICIAN ADVISED THAT THE PATIENT WAS COMPLIANT WITH ASPIRIN AND ANTICOAGULANTS. SECONDARY INTERVENTIONS WERE REQUIRED INCLUDING A RIGHT AXIAL BI-FEMORAL BYPASS, BILATERAL LOWER EXTREMITY FOUR COMPARTMENT FASCIOTOMY, LEFT FEMORAL TO ABOVE KNEE BYPASS, THROMBECTOMY OF THE RIGHT SUPERFICIAL FEMORAL ARTERY, THE POSTERIOR TIBIAL ARTERY AND THE ANTERIOR TIBIAL ARTERY. THE PATIENT IS IN CRITICAL CONDITION REQUIRES MEDICAL MANAGEMENT. MFR. REPORT # 1820334-2018-01604 FILED TO REPORT THROMBOSED MAIN BODY, MFR. REPORT # 1

  Patient problems: No Code Available; Pain; Thrombosis

  MAUDE report 7602392 ↗