Zenith Flex G48433Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002484334), received between Dec 12, 2014 and Dec 27, 2023 — classified as 2 deaths, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY FRACTURED. THE PATIENT HAD THE GRAFT PLACED DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) IN (B)(6) 2013. THE ULTRASOUND AND X-RAY IMAGES WERE NORMAL, AND NO ISSUES WERE NOTED DURING THE FOLLOW-UP OF 2022. DURING THE 2023 FOLLOW-UP, THERE WAS NO INCREASE IN THE ANEURYSM SAC SIZE PER ULTRASOUND IMAGING. HOWEVER, THE X-RAY IMAGING SHOWED THE SUPRARENAL FIXATION AND THE SUPRARENAL RING HAD BOTH FRACTURED OFF OF THE GRAFT. UPON THIS FINDING, A COMPUTED TOMOGRAPHY (CT) SCAN HAS BEEN REQUESTED. THE POSSIBLE OPTIONS ARE UNDER CONSIDERATION TO ADDRESS THE ISSUE: FENESTRATED CUFF IF CLINICALLY SUITABLE, BRACE TOP END WITH BARE METAL STENT IF NOT TOO FIT, OR NO INTERVENTION IF THE PATIENT IS UNFIT. A DECISION WILL BE MADE ON NEXT STEP OF TREATMENT AFTER THE PHYSICIAN DISCUSSES THESE OPTIONS WITH THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. THIS REPORT CAPTURES THE SUPRARENAL RING FRACTURE OFF OF THE GRAFT. ANOTHER REPORT WITH THE SAME PATIENT IDENTIFIER (B)(6) CAPTURES THE SUPRARENAL FIXATION FRACTURE OFF OF THE GRAFT.

  Patient problems: Insufficient Information

  MAUDE report 18401437 ↗
• MalfunctionDec 27, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: Insufficient Information

  MAUDE report 18401162 ↗
• MalfunctionAug 30, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CAPTOR VALVE OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY SHEATH LEAKED DURING USE. AS A RESULT, THE PATIENT LOST APPROXIMATELY ONE LITER OF BLOOD. THE DEVICE WAS THEN EXCHANGED FOR A COMPETITOR'S SHEATH TO SUCCESSFULLY COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE AND POST-PROCEDURE AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15324388 ↗
• DeathOct 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED AN UNKNOWN PATIENT RECEIVED A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IN 2016. SOME TIME AFTER THE PROCEDURE, THE BARE STENT BROKE OFF AND "IS IN PIECES". ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Aneurysm expansion; Clinical Endoleak; Great Vessel Perforation; Insufficient Information

  MAUDE report 12666866 ↗
• InjuryDec 18, 2018Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018. THE GRAFT WAS TAKEN OUT FROM THE PATIENT AFTER THEY DISCOVERED AN ENDOLEAK AND GROWTH OF THE ANEURYSM WITHOUT FIRST FINDING THE REASON FOR IT. AFTER FURTHER INVESTIGATION THEY COULD SEE LEAKAGE THROUGH THE FABRIC WHERE THE SUTURES ARE FIXED. SO A TYPE III ENDOLEAK WAS IDENTIFIED. THIS LEAK WAS DISCOVERED SEVERAL YEARS AFTER THE EVAR PROCEDURES WERE DONE.

  Patient problems: No Code Available

  MAUDE report 8176548 ↗
• DeathJul 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, A (B)(6) YEAR OLD MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA) UNDERWENT A PROCEDURE TO HAVE A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY IMPLANTED. THE IMPLANT COULD NOT BE DONE, SO THE PATIENT WAS CONVERTED TO CONVENTIONAL SURGERY. FURTHERMORE, IT WAS REPORTED THE PATIENT DIED. HOWEVER, THE DATE AND CAUSE OF DEATH WERE NOT PROVIDED. ON JULY 2, 2018, ADDITIONAL EVENT DETAILS WERE PROVIDED THAT A JUNIOR PARTNER DECIDED TO DO THE CASE ALONE. THE CASE WAS PERFORMED WITHOUT A COOK OR DISTRIBUTOR¿S REPRESENTATIVE OR EVEN THE SENIOR PARTNER (AND MOST EXPERIENCED USER/PHYSICIAN) PRESENT. THE JUNIOR PARTNER INITIALLY ALLEGED THAT THE DEVICE HAD A MALFUNCTION. A MEETING WAS HELD BETWEEN THE DISTRIBUTOR AND THE SENIOR PARTNER OF THE PRACTICE GROUP AND MOST EXPERIENCED USER OF THE DEVICE. THE SENIOR PARTNER CONFIRMED THE ZENITH GRAFT WAS DEPLOYED INCORRECTLY INSIDE OF THE PATIENT AS A RESULT OF USER ERROR. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL EVENT DETAILS, FURTHER DETAILS OF THE DEATH, AN AUTOPSY REPORT OR DEATH CERTIFICATE, IMAGING, AND THE DELIVERY SYSTEM HAVE BEEN REQUESTED BUT NOT RECEIVED AT THIS TIME.

  Patient problems: Death

  MAUDE report 7680495 ↗
• InjurySep 23, 2016Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 5972951 ↗
• MalfunctionFeb 20, 2015Difficult To Position; Difficult to Remove

  DURING AN EVAR PROCEDURE ON A MALE PT, THE PHYSICIAN ATTEMPTED TO RECOVER THE TOP CAP OF THE COOK MAIN BODY ENDOVASCULAR GRAFT BY PUSHING THE GRAY POSITIONER UP. THEY HAD SOME ISSUE PASSING THE GRAFT THROUGH AT THE LEVEL OF THE FLOW DIVIDER. THE PHYSICIAN WAS NOT ABLE TO ADVANCE THE GRAY POSITIONER. THEY THEREFORE ATTEMPTED TO PULL BACK THE TOP CAP TO MEET THE GRAY POSITIONER INSIDE THE GRAFT, BUT WHEN IT WAS AT 1 CM FROM THE GRAY POSITIONER IT STOPPED (IT WAS STUCK) AND THE PHYSICIAN WAS NOT ABLE TO REMOVE IT. PUSHING AND PULLING WERE ATTEMPTED TO ADVANCE THE SHEATH TO SUPPORT THE SYSTEM AND SOMETHING UNLOCKED. THE TOP CAP MET THE GRAY POSITIONER AND EVERYTHING WAS REMOVED. AFTER THE UNLOCK, THE PHYSICIAN NOTICED SOMETHING METALLIC (LIKE A WIRE) AT THE LEVEL WHERE GRAY POSITIONER AND TOP CAP WERE STUCK WHAT LOOKED LIKE AN INFOLDED STENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4548403 ↗
• MalfunctionDec 12, 2014Leak/Splash

  AN (B)(6) MALE PT UNDERWENT EVAR ON (B)(6) 2014. THE CAPTOR VALVE OF THE ZENITH FLEX MAIN BODY WOULD NOT SHUT OFF AND IT KEPT BLEEDING DURING ENTIRE PROCEDURE (1820334-2014-00658.) ALSO, A ZENITH MAIN BODY EXTENSION WAS USED AND IT WAS LEAKING BETWEEN THE CLEAR PLASTIC AND THE VALVE (1820334-2014-00659) AND SPRAYING EVERYWHERE. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 4351440 ↗