Zenith Flex G48478Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002484785), received between Oct 21, 2014 and Nov 4, 2014 — classified as 2 injuries.

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

• InjuryNov 4, 2014Occlusion Within Device

  ON (B)(6) 2013: A (B)(6) YR OLD MALE PT HAD UNDERGONE AAA REPAIR WITH RIGHT APPROACH. THE PT WAS SUITABLE FOR ENDOVASCULAR REPAIR AND THE PROCEDURE WAS CONDUCTED AS LABELED. ON (B)(6) 2013 (DAY UNK): RESECTION OF RECTAL CANCER WAS CONDUCTED. ON (B)(6) 2014 (DAY UNK): CT CONFIRMED PATENCY OF THE LEFT ILIAC LEG GRAFT. ON (B)(6) 2014 (DAY UNK): CT CONFIRMED SEVERE TORTUOSITY OF THE LEFT ILIAC LEG GRAFT. SINCE IT WAS FOUND AFTER RESECTION OF (B)(6) DEPARTMENT FOLLOWED UP. ON (B)(6) 2014: THE PT WAS REFERRED TO (B)(6) MEDICAL CTR DUE TO ISCHEMIA OF THE LOWER EXTREMITY. ON (B)(6) 2014: THE DOCTOR REPORTED THE EVENT TO THE SALES REP. ON (B)(6) 2014: FOR OCCLUSION OF THE LEFT ILIAC LEG GRAFT AFTER EVAR, COIL EMBOLIZATION IN THE APPROXIMATELY 20 MM OF SPACE FROM THE LEFT CIA TO BIFURCATION BETWEEN IIA AND EIA WAS PERFORMED, AND F-F BYPASS WAS ALSO CONDUCTED. SYMPTOM(S) OF THE ISCHEMIA OF THE LOWER EXTREMITY WAS IMPROVED.

  Patient problems: Surgical procedure, additional

  MAUDE report 4254551 ↗
• InjuryOct 21, 2014Dissection

  A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2014. THE PATIENT HAS RECEIVED DIALYSIS DUE TO CHRONIC RENAL FAILURE, SO THE VESSELS WERE CALCIFIED. THE LEFT COMMON ILIAC ARTERY WAS CALCIFIC AND STENOSED AS 4 MM. THE PROCEDURE CONSISTED OF PLACEMENT OF A MAIN BODY AND TWO ILIAC LEG GRAFTS. THE ILIAC LEG GRAFT FOR THE LEFT SIDE DIDN'T EXPAND ENOUGH DUE TO THE CALCIFIC AND STENOSED VESSEL CONDITION. SO THE USER STRONGLY DILATED THE STENT GRAFT USING A CODA BALLOON. THE PHYSICIAN THINKS IT DAMAGED THE LEFT COMMON ILIAC ARTERY (1820334-2014-00530). BY FINAL ANGIO, LARGE AMOUNT OF TYPE IV ENDOLEAK WAS CONFIRMED AND IT WAS RESOLVED BY PLACING A BODY EXTENSION WHICH WAS INSERTED FROM THE RIGHT FEMORAL (1820334-2014-00521). FIVE MINUTES AFTER PLACING THE BODY EXTENSION, DAMAGE IN THE LEFT COMMON ILIAC ARTERY WAS CONFIRMED.. THE DAMAGE WAS TREATED BY PLACING 20 MM OF ANOTHER MANUFACTURER'S EXCLUDER LEG AND THE PROCEDURE WAS COMPLETED (1820334-2014-00530). THE PATIENT HAS NOT SHOWN PROBLEMATIC SYMPTOMS.

  Patient problems: Vascular Dissection

  MAUDE report 4209640 ↗