Zenith G32539Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10827002325392), received between May 22, 2018 and Mar 10, 2026 — classified as 12 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

111 other recalls cover devices cleared under the same FDA submission (P020018); they may or may not involve this specific model.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Fluid/Blood Leak

  TYPE 3 ENDOLEAK WAS REPORTED. THE IMAGING RECEIVED CONFIRMED A TYPE 4 ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 24554822 ↗
• InjuryDec 31, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AT THE CONCLUSION OF THE IMPLANT PROCEDURE, THERE WAS A LEAK SEEN IN-BETWEEN THE TWO COMPONENTS. THE DEVICE WAS IMPLANTED; AT THE FINAL IMAGING RUN THERE WAS A BIG RUSH OF A LEAK SEEN. IT WAS THOUGHT TO BE EITHER A TYPE 3 OR A TYPE 4 ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 23933522 ↗
• InjuryDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AT THE CONCLUSION OF THE IMPLANT PROCEDURE, THERE WAS A LEAK SEEN IN-BETWEEN THE TWO COMPONENTS. THE DEVICE WAS IMPLANTED, AT THE FINAL IMAGING RUN THERE WAS A BIG RUSH OF A LEAK SEEN. IT WAS THOUGHT TO BE EITHER A TYPE 3 OR A TYPE 4 ENDOLEAK. ADDITIONAL INFORMATION RECEIVED: WHAT KIND OF ANTI-PLATELET OR ANTI-COAGULATION THERAPY WAS THE PATIENT ON? -THE PATIENT WAS FULLY HEPARINIZED DURING THE CASE. WILL THERE BE ANY ADDITIONAL PROCEDURES REQUIRED TO FIX THE REPORTED ENDOLEAK? -HE WILL GET ANOTHER SCAN IN A FEW MONTHS TO SEE IF LEAK IS STILL PRESENT. CONSIDERING A PALMAZ STENT IF LEAK IS STILL PRESENT IN FUTURE SCAN. WAS ANY DIFFICULTY EXPERIENCED DURING DEPLOYMENT? -NO DIFFICULTY DURING DEPLOYMENT. WHAT DOES THE PHYSICIAN THINK CAUSED THE ENDOLEAK? -HE THINKS THE GRAFT IS NOT FULLY APPOSED AND WAS QUESTIONING THE DIAMETERS OF DEVICE AND IF IT WAS 24 IN A 24. HE WAS CONCERNED HE WAS GIVEN A SMALLER DIAMETER. HOW MUCH OVERLAP WAS BETWEEN DISTAL AND PROXIMAL DEVICE? THE DISTAL BOFY WAS BROUGHT UP THE CROSS HAIRS -3 STENTS. WHAT IS THE CURRENT PATIENT CONDITION -PATIENT IS STABLE WITH PERSISTENT TYPE 3 LEAK. WAITING FOR RESCAN TO SEE HOW HE DOES AND IF REINTERVENTION IS NEEDED THEN.

  Patient problems: Clinical Endoleak

  MAUDE report 23861684 ↗
• MalfunctionApr 29, 2024Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  THE GRAFT WAS UNSHEATHED IN THE PATIENT BUT STILL ATTACHED TO THE DELIVERY SYSTEM. AT THIS POINT, THE GRAFT LOOKED TWISTED AROUND ITSELF ON FLUORO. THE DELIVERY SYSTEM HAD TO BE MANIPULATED AND TWISTED TO MOSTLY UNTWIST THE GRAFT. IT WAS NEVER FULLY UNTWISTED, BUT THE PATIENT'S ANEURYSM SEALED. THEY WENT TO RELEASE FROM THE DELIVERY SYSTEM AND THE BLACK TRIGGER WIRE WAS VERY DIFFICULT TO GET OUT, BUT IT DID EVENTUALLY WORK. THEN, THE WHITE TRIGGER WIRE WAS VERY DIFFICULT TO REMOVE AND SNAPPED OFF AND BROKE WHILE TRYING TO REMOVE. THEY TRIED TO USE HEMOSTATS TO REMOVE THE REMAINDER OF THE WHITE TRIGGER WIRE AND THAT KEPT SHREDDING THE TRIGGER WIRE BECAUSE IT WAS SO DIFFICULT TO PULL OUT. THEY HAD TO ROTATE THE DEVICE A LOT MORE AND WERE FINALLY ABLE TO GET THE WIRE OUT. THEY WERE THEN ABLE TO CONTINUE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH THE DEVICE IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19210294 ↗
• InjuryJun 12, 2023Material Twisted/Bent; Material Twisted/Bent

  PER REP - (B)(6) 2023 - EVERYTHING WAS DEPLOYED CORRECTLY. THE MAIN WIRE THAT THE DEVICE WAS DEPLOYED OVER GOT PULLED BACK. THEN THEY REWIRED INTO THE DEVICE AND PUT UP A CODA BALLOON WHICH WOULD NOT TRACK OVER THE WIRE THROUGH THE DEVICE. AT THAT POINT, THEY TOOK AN ANGIOGRAM AND REALIZED THAT THE DEVICE HAD TWISTED AND COVERED THE SMA AND RIGHT RENAL ARTERY. AT THAT POINT, THE PHYSICIAN DECIDED TO DO AN OPEN REPAIR. THE PATIENT LIVED COMING OFF THE TABLE.

  Patient problems: Failure of Implant

  MAUDE report 17108016 ↗
• InjuryJun 1, 2023Material Twisted/Bent; Material Twisted/Bent

  THE SALES REPRESENTATIVE ADVISED THAT EVERYTHING WAS DEPLOYED CORRECTLY DURING THE FEVAR PROCEDURE. THE MAIN WIRE THAT THE DEVICE WAS DEPLOYED OVER GOT PULLED BACK. THEN THEY REWIRED INTO THE DEVICE AND PUT UP A CODA BALLOON WHICH WOULD NOT TRACK OVER THE WIRE THROUGH THE DEVICE. AT THAT POINT, THEY TOOK AN ANGIOGRAM AND REALIZED THAT THE DEVICE HAD TWISTED AND COVERED THE SMA AND RIGHT RENAL ARTERY. AT THAT POINT, THE PHYSICIAN DECIDED TO DO AN OPEN REPAIR. THE PATIENT LIVED COMING OFF THE TABLE.

  Patient problems: Failure of Implant

  MAUDE report 17036217 ↗
• InjuryDec 19, 2022Difficult or Delayed Activation; Material Twisted/Bent; Physical Resistance/Sticking

  AN 84-YEAR-OLD MALE PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) IN WHICH A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY WAS USED. THE PROXIMAL TRIGGER WIRE GOT STUCK AND WOULD NOT DEPLOY CORRECTLY. THE PHYSICIAN PULLED REALLY HARD ON THE TRIGGER WIRE AND THE GRAFT EVENTUALLY DEPLOYED. WHILE THE TRIGGER WIRE MECHANISM WAS PULLED, THE TOP CAP WAS BENDING WITH THE WIRE INSTEAD OF BEING RELEASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16002038 ↗
• InjuryDec 19, 2022Migration; Fluid/Blood Leak; Migration

  A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR IN (B)(6) 2018 IN WHICH A ZENITH FENESTRATED GRAFT WAS IMPLANTED. THE PATIENT WAS LOST TO FOLLOW- UP FOR QUITE SOME TIME, HOWEVER, CAME BACK RECENTLY FOR A FOLLOW UP. PER RECENT SCAN THE PHYSICIAN DETECTED A POSSIBLE TYPE 1A ENDOLEAK. THE PHYSICIAN IS PLANNING A FOLLOW UP PROCEDURE BUT NOT SCHEDULED AS OF YET. FOR THE FOLLOW UP PROCEDURE THE PHYSICIAN WILL BE PLACING A NON-COOK MANUFACTURED STENT.

  Patient problems: Clinical Endoleak

  MAUDE report 16001996 ↗
• InjuryDec 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ACCORDING TO THE INITIAL REPORTER: A PATIENT OF UNDISCLOSED GENDER AND AGE UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR IN JANUARY 2018 IN WHICH A ZENITH FENESTRATED GRAFT WAS IMPLANTED. THE PATIENT WAS LOST TO FOLLOW- UP FOR QUITE SOME TIME, HOWEVER, CAME BACK RECENTLY FOR A FOLLOW UP. PER RECENT SCAN THE PHYSICIAN DETECTED A POSSIBLE TYPE 1A ENDOLEAK. THE PHYSICIAN IS PLANNING A FOLLOW UP PROCEDURE BUT NOT SCHEDULED AS OF YET. FOR THE FOLLOW UP PROCEDURE THE PHYSICIAN WILL BE PLACING A NON-COOK MANUFACTURED STENT.

  Patient problems: Insufficient Information

  MAUDE report 15994817 ↗
• InjuryDec 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AS REPORTED VIA (B)(6) BY THE PHYSICIAN "2ND IMAGE IT'S FROM 2019. PLEASE NOTE RENAL STENTS FACING EACH OTHER. LAST IMAGE DONE RECENTLY SHOWS RENAL STENT FACING DOWNWARD DUE TO MIGRATION. FIRST IMAGE, CATHETER THROUGH THE LARGE SUPERIOR MESENTERIC ARTERY (SMA) FEN WITH CONTRAST FILLING THE SAC. THE FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) WAS DONE 2019 LOCALLY, SENT TO ME FOR TYPE 2 ENDOLEAK. ANGIO REVEALS TYPE 1A. LARGE SMA FEN PARTIALLY COVERING SMA DUE TO STENT MIGRATION. 60 YEAR OLD MALE BUT WITH SEVERE MR AND PULM HTN."

  Patient problems: No Code Available

  MAUDE report 11029151 ↗
• InjuryDec 6, 2020Break; Migration; Break

  AS REPORTED VIA TWITTER BY THE PHYSICIAN "2ND IMAGE IT'S FROM 2019. PLEASE NOTE RENAL STENTS FACING EACH OTHER. LAST IMAGE DONE RECENTLY SHOWS RENAL STENT FACING DOWNWARD DUE TO MIGRATION. FIRST IMAGE, CATHETER THROUGH THE LARGE SUPERIOR MESENTERIC ARTERY (SMA) FEN WITH CONTRAST FILLING THE SAC. THE FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) WAS DONE 2019 LOCALLY, SENT TO ME FOR TYPE 2 ENDOLEAK. ANGIO REVEALS TYPE 1A. LARGE SMA FEN PARTIALLY COVERING SMA DUE TO STENT MIGRATION. 60 YEAR OLD MALE BUT WITH SEVERE MR AND PULM HTN."

  Patient problems: No Code Available

  MAUDE report 10955709 ↗
• InjuryJan 8, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING CAT SCAN THE PHYSICIAN NOTED THAT THE PROXIMAL / DISTAL DEVICES HAD SEPARATED CAUSING AND TYPE III ENDOLEAK. PATIENT IS SCHEDULED FOR AN INTERVENTION ON MONDAY ((B)(6) 2019). SECONDARY INTERVENTION WAS PERFORMED ON (B)(6) 2019 AT C13984-1. THE PHYSICIAN PLACED 2 ADDITIONAL GRAFTS (ZDEG-P-28-82-PF-US AND A ESBE-28-58-ZT) INSIDE THE PROXIMAL AND DISTAL ZFEN GRAFTS TO BRIDGE THE GAP AND SEAL THE DEVICES. FINAL ANGIOGRAM LOOKED GOOD AND SHOWED NO EVIDENCE OF ENDOLEAK.

  Patient problems: No Code Available

  MAUDE report 9563480 ↗
• InjuryJan 6, 2020Leak/Splash; Detachment of Device or Device Component

  DURING CAT SCAN THE PHYSICIAN NOTED THAT THE PROXIMAL / DISTAL DEVICES HAD SEPARATED CAUSING A TYPE III ENDOLEAK. SECONDARY INTERVENTION WAS PERFORMED ON (B)(6) 2019. THE PHYSICIAN PLACED 2 ADDITIONAL GRAFTS ( ZDEG-P-28-82-PF-US AND A ESBE-28-58-ZT) INSIDE THE PROXIMAL AND DISTAL ZFEN GRAFTS TO BRIDGE THE GAP AND SEAL THE DEVICES. FINAL ANGIOGRAM LOOKED GOOD AND SHOWED NO EVIDENCE OF ENDOLEAK.

  Patient problems: Failure of Implant

  MAUDE report 9551139 ↗
• InjuryMay 22, 2018Leak/Splash

  THIS GRAFT WAS IMPLANTED ON (B)(6) 2015. THERE WAS NO REAL ISSUES. IT MAY HAVE HAD A SLIGHT TYPE I ENDOLEAK AND THEY WANTED TO FOLLOW PATIENT. IN THE PROCEDURE THAT WAS THE SECONDARY ONE THAT WAS PERFORMED ON (B)(6) 2018. THE PATIENT WAS BROUGHT IN AND ACCESSED WITH BRACHIAL CUT DOWN ON THE LEFT ARM. INITIALLY A 6 X 70 ANSEL SHEATH WAS USED BUT WAS NOT LONG ENOUGH TO REACH THE RENAL. IT WAS CHANGED TO 7 X 90 PINNACLE SHEATH. THE RIGHT RENAL WAS THEN CANNULATED WITH AN ANGLED GLIDE CATHETER. AN ANGIOGRAPHY WAS PERFORMED AND NO LEAK WAS VISIBLE OR ISSUE IN THE RENAL. A ROSEN WIRE WAS THEN EXCHANGED AND THE LARGE FLASH OSTIAL DUAL LUMEN BALLOON WAS USED TO SUPPORT THE RENAL STENT AND FLARE THE BACK END. THE STENT SEEMED TO FLARE WELL. THEN ANOTHER ANGIOGRAPHY WAS DONE. THIS THEN SHOWED A MORE OBVIOUS TYPE I ENDOLEAK ON THE DISTAL OR BOTTOM PORTION OF THE FENESTRATION INTO THE SACK. A GAP COULD BE SEEN BETWEEN THE STENT AND THE GOLD MARKS. FROM HERE ACCESS WAS OBTAINED PERCUTANEOUSLY THROUGH THE LEFT GROIN AND THEN A 6 FR SHEATH WAS BROUGHT UP TO TRY TO CANNULATE THE SMALL OPENING ON THE FENESTRATION. AFTER MANY ATTEMPTS THE PHYSICIAN WENT BACK TO THE WIRE AND SHEATH COMING FROM THE AR

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7535679 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020018. One submission often covers many models, so check the product and lot details in each record.

• Z-3143-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-73-ZT, REF G48462, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3155-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-90-ZT, REF G48479, 16 Fr. ID/ 6.0 OD, Sterile.
• Z-3131-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-96-ZT, REF G48408, 18 Fr ID/ 7.1 mm OD, Sterile
• Z-3146-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-73-ZT, REF G48466, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3154-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-24-73-ZT, REF G48478, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3147-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48469, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3153-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48477, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3145-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-18-56-ZT, REF G48465, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3130-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-24-82-ZT, REF G48407, 18 Fr ID/ 7.1 mm OD, Sterile
• Z-3156-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-22-29, REF G32179, 18 Fr. ID/ 6.90 OD, Sterile.
• Z-3157-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-30-39, REF G32183, 20 Fr. ID/ 7.7 OD, Sterile.
• Z-3150-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-56-ZT, REF G48473, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3136-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-82-ZT, REF G48427, 20 Fr ID/ 7.7 mm OD, Sterile.
• Z-3158-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Main Body Extension, REF ESBE-32-39, REF G32184, 20 Fr. ID/ 7.7 mm OD, Sterile.
• Z-3149-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 16Fr ID/ 6.0 mm OD, Sterile.

…and 96 more.