Zenith G32554Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10827002325545), received between Jan 14, 2018 and May 7, 2026 — classified as 2 deaths, 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2026Fluid/Blood Leak

  BOTH COMPONENTS WERE PLACED, THEN THERE WAS A PERSISTENT LEAK AT THE DISTAL END, THAT WOULD NOT STOP. THEY TRIED TO RE-BALLOON BUT THIS DID NOT RESOLVE THE ISSUE. THEY RESOLVED THE ISSUE BY RELINING THE FENESTRATED GRAFT USING A 28MM (ANOTHER MANUFACTURER) GRAFT INSTEAD. (ANOTHER MANUFACTURER) GRAFT PLACEMENT WAS AN ADDITIONAL PROCEDURE, AND THEY PLACED TWO ADDITIONAL LIMBS WITH THE GRAFT AS WELL.) THE PLAN FOR FOLLOW UP IS TO DO A CTA.

  Patient problems: Clinical Endoleak

  MAUDE report 25115919 ↗
• InjuryApr 24, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  BOTH COMPONENTS WERE PLACED, THEN THERE WAS A PERSISTENT LEAK AT THE DISTAL END, THAT WOULD NOT STOP. THEY TRIED TO RE-BALLOON BUT THIS DID NOT RESOLVE THE ISSUE. THEY RESOLVED THE ISSUE BY RELINING THE FENESTRATED GRAFT USING A 28MM GORE GRAFT INSTEAD. (GORE GRAFT PLACEMENT WAS AN ADDITIONAL PROCEDURE, AND THEY PLACED TWO ADDITIONAL LIMBS WITH THE GRAFT AS WELL.) THE PLAN FOR FOLLOW UP IS TO DO A CTA.

  Patient problems: Clinical Endoleak

  MAUDE report 24991104 ↗
• MalfunctionMar 8, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  ENDOLEAK BELIEVE TO BE A CROTCH TEAR. RELINED WITH A COMPETITORS GRAFT THE SAME DAY AND THE PROBLEM WAS FIXED. ADDITIONAL INFORMATION RECEIVED: THE TEAR WAS DISCOVERED DURING THE COMPLETION ANGIO. NO DIFFICULTY WAS EXPERIENCED DURING DEPLOYMENT. AFTER RELINING WITH ANOTHER GRAFT TO TRY TO ELIMINATE THE LEAK, THE PATIENT IS COMPLETELY FINE AND NO LEAK. THE PHYSICIAN IS NOT SURE WHAT CAUSED THE ISSUE: EITHER BALLOONING THE BIFURCATION (WITH A 32 CODA - THE BALLOONING TECHNIQUE USED WAS BALLOONING EACH LEG SEPARATELY WITH THE CODA) OR A MANUFACTURING DEFECT.

  Patient problems: Clinical Endoleak

  MAUDE report 24541691 ↗
• MalfunctionMar 7, 2023Material Twisted/Bent

  WHEN THEY PUT THE DEVICE OVER THE PATIENT'S ABDOMEN TO ORIENT IT, THEY COULD TELL THAT THE CONTRALATERAL GATE WAS TWISTED WITHIN THE SHEATH. THE DEVICE WAS NOT USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16493501 ↗
• InjuryJun 23, 2021Complete Blockage; Complete Blockage

  THERE WAS A CLOT THAT FORMED IN THE OVERLAP OF THE DEVICE AND OF A SECOND DEVICE. A COVERED VBX STENT WAS PLACED TO FLATTEN THE CLOT AND OPEN UP THE LIMB A BIT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12049884 ↗
• InjuryJun 21, 2021Leak/Splash; Leak/Splash

  A SUPPOSED TYPE III ENDOLEAK WAS FOUND ON A FOLLOW UP CTA. THE CTA AND SUBSEQUENT ANGIOGRAM SHOWS HIGHLIGHTING OF CONTRAST NEXT TO THE CONTRALATERAL GATE JUST DISTAL TO THE BIFURCATION OF THE DISTAL BODY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12031701 ↗
• InjuryJun 16, 2021Obstruction of Flow; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  THERE WAS A CLOT THAT FORMED IN THE OVERLAP OF THE DEVICE AND OF A SECOND DEVICE. A COVERED VBX STENT WAS PLACED TO FLATTEN THE CLOT AND OPEN UP THE LIMB A BIT.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 12014266 ↗
• InjuryJun 7, 2021Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  A SUPPOSED TYPE III ENDOLEAK WAS FOUND ON A FOLLOW UP CTA. THE CTA AND SUBSEQUENT ANGIOGRAM SHOWS HIGHLIGHTING OF CONTRAST NEXT TO THE CONTRALATERAL GATE JUST DISTAL TO THE BIFURCATION OF THE DISTAL BODY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11948666 ↗
• InjuryDec 11, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  2 MONTHS POST DEPLOYMENT, PHYSICIAN SAW A LEAK ON CT DURING FOLLOW-UP (RIGHT LIMB OR DISTAL FENESTRATED PIECE HAD AN ENDOLEAK, BUT EXACT LOCATION COULD NOT BE DETERMINED...POSSIBLY BOTH. LEAK BELIEVED TO BE TYPE 3. PHYSICIAN SCHEDULED PATIENT FOR FOLLOW-UP PROCEDURE. PATIENT BROUGHT IN FOR LIMB EXTENSION OR CUFF PROCEDURE, IT WAS UNSURE WHAT WOULD BE NEEDED. NUMBEROUS ANGIO RUNS WERE DONE. RIGHT LIMB WAS REDONE FROM TOP TO BOTTOM. USER BALLOONED DEVICE, DID ANOTHER ANGIO RUN, SAW A BIT MORE LEAKING, DID BOTH SIDES (BROUGHT UP 2 14X4 ATLAS BALLOONS, "KISSING BALLOONS", TO TRY TO INFLATE IT ALL TO EXPAND IT, DID ANOTHER ANGIO WHICH IMPROVED SITUATION A BIT MORE BUT IT WAS STILL LEAKING A LITTLE BIT FROM AN UNDETERMINED LOCATION. USER ENDED UP IMPLANTING WITH GORE LIMBS: 20X16X100 (2 EA, ONE ON LEFT SIDE AND ONE ON RIGHT). USER USED CODA BALLOONS ON BOTH SIDES, INFLATED, WENT UP AND DID A FINAL RUN, AND ENDOLEAK APPEARED TO BE GONE.

  Patient problems: No Code Available

  MAUDE report 10992429 ↗
• InjuryNov 29, 2020Leak/Splash; Material Split, Cut or Torn; Material Split, Cut or Torn

  2 MONTHS POST DEPLOYMENT, PHYSICIAN SAW A LEAK ON CT DURING FOLLOW-UP (RIGHT LIMB OR DISTAL FENESTRATED PIECE HAD AN ENDOLEAK, BUT EXACT LOCATION COULD NOT BE DETERMINED...POSSIBLY BOTH. LEAK BELIEVED TO BE TYPE 3. PHYSICIAN SCHEDULED PATIENT FOR FOLLOW-UP PROCEDURE. PATIENT BROUGHT IN FOR LIMB EXTENSION OR CUFF PROCEDURE, IT WAS UNSURE WHAT WOULD BE NEEDED. NUMBEROUS ANGIO RUNS WERE DONE. RIGHT LIMB WAS REDONE FROM TOP TO BOTTOM.USER BALLOONED DEVICE, DID ANOTHER ANGIO RUN, SAW A BIT MORE LEAKING, DID BOTH SIDES (BROUGHT UP 2 14X4 ATLAS BALLOONS, "KISSING BALLOONS", TO TRY TO INFLATE IT ALL TO EXPAND IT, DID ANOTHER ANGIO WHICH IMPROVED SITUATION A BIT MORE BUT IT WAS STILL LEAKING A LITTLE BIT FROM AN UNDETERMINED LOCATION. USER ENDED UP IMPLANTING WITH GORE LIMBS: 20X16X100 (2 EA, ONE ON LEFT SIDE AND ONE ON RIGHT). USER USED CODA BALLOONS ON BOTH SIDES, INFLATED, WENT UP AND DID A FINAL RUN, AND ENDOLEAK APPEARED TO BE GONE.

  Patient problems: No Code Available

  MAUDE report 10916257 ↗
• InjuryNov 3, 2020Appropriate Device Problem Term/Code Not Available

  THE ZFEN WAS PLACED (B)(6) 2020. LEAK WAS THOUGHT TO BE POTENTIAL TYPE LL AND WE WOULD RE-EVALUATE. 30 DAY CT FOLLOW UP WAS PERFORMED AND SIGNIFICANT ENDOLEAK WAS STILL APPRECIATED. DIAGNOSTIC ANGIOGRAMS CONFIRMED TYPE LLL, THOUGHT TO BE TEAR OF DEFECT IN FLOW DIVIDER. PATIENT WAS RESCHEDULED TO RELINE.

  Patient problems: No Code Available

  MAUDE report 10777641 ↗
• InjuryOct 20, 2020Material Split, Cut or Torn; Leak/Splash; Defective Device; Material Split, Cut or Torn

  THE ZFEN WAS PLACED (B)(6) 2020. LEAK WAS THOUGHT TO BE POTENTIAL TYPE LL AND WE WOULD RE-EVALUATE. 30 DAY CT FOLLOW UP WAS PERFORMED AND SIGNIFICANT ENDOLEAK WAS STILL APPRECIATED. DIAGNOSTIC ANGIOGRAMS CONFIRMED TYPE LLL, THOUGHT TO BE TEAR OF DEFECT IN FLOW DIVIDER. PATIENT WAS RESCHEDULED TO RELINE.

  Patient problems: No Code Available

  MAUDE report 10706648 ↗
• DeathDec 10, 2019Failure to Advance

  UPON THE FINAL RUN, THE CELIAC AND SUPERIOR MESENTERIC ARTERY (SMA) WERE NOT VISUALIZED. MORE IMAGING WAS DONE TO SEE THE VESSELS BETTER. STILL NO VISUALIZATION. THE ARM ACCESS WAS USED TO GET IN FROM ABOVE. ONE VESSEL WAS CANNULATED, BUT A 7FR SHEATH WOULD NOT PASS INTO THE VESSEL. ACCESS WAS LOST, BUT A 6FR SHEATH WAS ADVANCED, AND ACCESS TO THE CELIAC WAS GAINED. A BARE-METAL STENT WAS DEPLOYED. THERE WERE SEVERAL TRIES TO GET INTO THE SMA, BUT ACCESS WAS NEVER GAINED. THE PHYSICIANS MADE THE DECISION TO OPEN THE ABDOMEN TO TRY TO GET A RETROGRADE STENT INTO THE SMA. PATIENT PASSED AFTER HE WAS MOVED FROM THE OPERATING ROOM TABLE.

  Patient problems: Death

  MAUDE report 9447791 ↗
• DeathDec 2, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING INTO THE INITIAL REPORTER, DURING A FENESTRATED ABDOMINAL ZFEN PROCEDURE, UPON THE FINAL RUN THE SMA AND CELIAC WERE NOT VISUALIZED. THE PHYSICIAN BELIEVES THE INITIAL PROCEDURE WAS CAUSE FOR AN ADDITIONAL PROCEDURE; THE PATIENT HAD TO HAVE OPEN ABDOMINAL SURGERY. (THE PATIENT¿S ABDOMEN WAS OPENED TO TRY TO STENT THE SMA RETROGRADE.) PATIENT PASSED AFTER HE WAS MOVED FROM THE OR TABLE.

  Patient problems: Death

  MAUDE report 9394787 ↗
• InjuryOct 1, 2019Leak/Splash

  THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2018 TO REPAIR AN ABDOMINAL ANEURYSM. A ZFEN-P-2-34-137-R (LOT AC1025994), ZFEN-D-12-28-91-C (LOT AC1025995), ZSLE-13-56-ZT (LOT 8966438), AND ZSLE-16-56-ZT (LOT 9037918) WERE PLACED. A TYPE 4 ENDOLEAK WAS NOTED AND APPEARS TO BE WITH THE LEFT COMMON ILIAC. A ZSLE-13-39-ZT (LOT 8409848) WAS PLACED TO RELINE. THE PHYSICIAN DECIDED TO WAIT 30 DAYS FOR THE ENDOLEAK TO RESOLVE. THE ENDOLEAK DID NOT RESOLVE ON ITS OWN. ON (B)(6) 2019 THE PHYSICIAN WENT IN TO SEE IF A COOK CUFF COULD BE PLACED AS THE LEAK WAS NOW BELIEVED TO BE ABOVE FLOW DIVIDER AT THE DISTAL GRAFT. FOCAL LEAK COULD NOT BE IDENTIFIED ON CTA OR SELECTIVE ANGIOGRAMS, SO THE FEVAR STENT WAS 80% RELINED WITH BILATERAL TWO GORE LIMBS AND A GORE CUFF. ENDOLEAK PERSISTED A MONTH LATER AND STILL APPEARED DIFFUSE, SO STENT WAS RELINED A SECOND TIME UP TO RENAL FENESTRATIONS AND CONVERTED TO AORTO-UNI-ILIAC AND FEM-FEM, WHICH RESULTED IN COMPLETE RESOLUTION OF LEAK. PATIENT CONTINUES TO DO WELL AFTER COMPLETE RELINING WITH NO FURTHER ENDO LEAKS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9141855 ↗
• InjurySep 25, 2019Leak/Splash

  THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2018 TO REPAIR AN ABDOMINAL ANEURYSM. A ZFEN-P-2-34-137-R (LOT AC1025994), ZFEN-D-12-28-91-C (LOT AC1025995), ZSLE-13-56-ZT (LOT 8966438), AND ZSLE-16-56-ZT (LOT 9037918) WERE PLACED. A TYPE 4 ENDOLEAK WAS NOTED AND APPEARS TO BE WITH THE LEFT COMMON ILIAC. A ZSLE-13-39-ZT (LOT 8409848) WAS PLACED TO RELINE. THE PHYSICIAN DECIDED TO WAIT 30 DAYS FOR THE ENDOLEAK TO RESOLVE. THE ENDOLEAK DID NOT RESOLVE ON ITS OWN. ON (B)(6) 2019 THE PHYSICIAN WENT IN TO SEE IF A COOK CUFF COULD BE PLACED AS THE LEAK WAS NOW BELIEVED TO BE ABOVE FLOW DIVIDER AT THE DISTAL GRAFT. FOCAL LEAK COULD NOT BE IDENTIFIED ON CTA OR SELECTIVE ANGIOGRAMS, SO THE FEVAR STENT WAS 80% RELINED WITH BILATERAL TWO GORE LIMBS AND A GORE CUFF. ENDOLEAK PERSISTED A MONTH LATER AND STILL APPEARED DIFFUSE, SO STENT WAS RELINED A SECOND TIME UP TO RENAL FENESTRATIONS AND CONVERTED TO AORTO-UNI-ILIAC AND FEM-FEM, WHICH RESULTED IN COMPLETE RESOLUTION OF LEAK. PATIENT CONTINUES TO DO WELL AFTER COMPLETE RELINING WITH NO FURTHER ENDOLEAKS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9120811 ↗
• InjuryJan 14, 2018Leak/Splash; Material Separation

  AFTER THE AORTA WAS REMODELED, THE TWO GRAFTS PULLED APART CAUSING A TYPE 3 ENODLEAK.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7188706 ↗

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-3140-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-12-56-ZT, REF G48449, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3134-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-28-96-ZT, REF G48418, 20 Fr ID/ 7.7 mm OD, Sterile
• Z-3151-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-22-73-ZT, REF G48474, 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-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-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-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-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-3142-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-56-ZT, REF G48461, 16Fr ID/ 6.0 mm 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-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-3137-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-32-96-ZT, REF G48428, 20 Fr ID/ 7.7 mm OD, Sterile.
• Z-3148-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48470, 16Fr ID/ 6.0 mm OD, Sterile.
• Z-3138-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-36-95-ZT, REF G48432, 22 Fr ID/ 8.5 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.

…and 96 more.