Zenith Flex G48414Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002484143), received between Aug 16, 2016 and Jun 29, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 3B ENDOLEAK RESULTING FROM A FABRIC TEAR AT THE SITE OF ANGULATION WAS DISCOVERED ON A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IN AN UNKNOWN PATIENT. AS A RESULT OF THE ENDOLEAK, THE INTERNAL ILIAC ARTERY WAS EMBOLIZED AND THE LEFT ILIAC SYSTEM WAS RELINED WITH A NEW STENT GRAFT. ADDITIONAL INFORMATION REGARDING EVENT AND PATIENT DETAILS HAVE BEEN REQUESTED, BUT ARE CURRENTLY UNAVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 14862042 ↗
• InjuryMar 14, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A TYPE 1A ENDOLEAK OCCURRED ON A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DEVICE FOLLOWING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. A TAX INVOICE DATED (B)(6) 2012 INDICATED THAT DURING THE INDEX PROCEDURE, THE PATIENT RECEIVED THREE COOK DEVICES INCLUDING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY AND TWO ILIAC LEG GRAFTS. A TAX INVOICE DATED (B)(6) 2020 INDICATED THE PATIENT RECEIVED TWO BIFURCATED ILIAC SIDE BRANCH GRAFTS. A HANDWRITTEN INVOICE DATED (B)(6) 2020 INDICATED THE USE OF A SNARE AND A CODA BALLOON. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. IT WAS DISCOVERED THERE WAS ANEURYSM GROWTH DUE TO A TYPE 1A ENDOLEAK ON THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY DEVICE. IT WAS NOTED THE PATIENT HAS OPTED TO BE TREATED BY OPEN SURGERY. AT THIS TIME, IT IS UNCLEAR IF THE OPEN SURGERY HAS BEEN PERFORMED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Abdominal Pain; Aneurysm

  MAUDE report 13763164 ↗
• InjuryJan 4, 2022Entrapment of Device; Malposition of Device; Material Deformation; Entrapment of Device; Malposition of Device; Material Deformation

  IT WAS REPORTED THAT A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY GRAFT WAS DISPLACED DURING A BIFURCATED ENDOPROSTHESIS IMPLANT PROCEDURE AND EXTENSIONS. FOLLOWING THE RELEASE OF THE GRAFT, TWO SAFETY WIRES WERE REMOVED AND AN ATTEMPT WAS MADE TO RECOVER THE TOP CAP. SOMETHING WAS REPORTED TO HAVE GOTTEN STUCK AS THE GRAY SYSTEM WAS ADVANCED AND REMOVAL BEGAN. THIS ACTION CAUSED DISPLACEMENT OF THE ENDOPROSTHESIS THAT COVERED THE CELIAC TRUNK. WHEN REMOVING THE SHEATH, A DEFORMATION WAS NOTICED NEAR WHERE IT WAS RELEASED. IMMEDIATELY, A LAPAROTOMY WITH INFRA-RENAL AORTIC ANEURYSMECTOMY AND ENDOPROSTHESIS EXPLANT WAS PERFORMED. THE PROCEDURE WAS COMPLETED POST-COMPLICATION. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 13158921 ↗
• InjuryAug 16, 2016Occlusion Within Device; Occlusion Within Device

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A PROCEDURE TO TREAT AN ABDOMINAL ANEURYSM. THE USER FACILITY REPORTED THAT THE MAIN BODY HAD MIGRATED. HOWEVER, THE CLINICAL SPECIALIST VISITED THE PHYSICIAN TO CONFIRM THE REPORT AND DISCOVERED THAT THE GRAFT HAD NOT MIGRATED BUT THE LEFT RENAL WAS OCCLUDED. THE OCCLUSION OCCURRED POST IMPLANT OF THE GRAFT. ON (B)(6) 2016, THE PATIENT HAD A SUCCESSFUL RENAL STENT PLACED IN THE LEFT RENAL. THE PATIENT'S PREVIOUSLY OCCLUDED LEFT RENAL ARTERY IS NOW OPEN AND THE PATIENT IS DOING FINE

  Patient problems: Occlusion

  MAUDE report 5878324 ↗