Zenith G32562Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10827002325620), received between Jun 29, 2015 and Feb 13, 2026 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  ACCORDING TO THE INITIAL REPORTER: DURING THE ORIGINAL IMPLANT ON (B)(6) 2025, AN ENDOLEAK WAS OBSERVED, BUT ITS CAUSE HAD NOT BEEN CONFIRMED AT THE TIME. A FOLLOW-UP CT SCAN ON (B)(6) 2025, SHOWED THAT THE ANEURYSM HAD GROWN BY 0.5 CM. ANOTHER CT SCAN ON (B)(6) 2025, REVEALED AN ADDITIONAL 1.0 CM OF GROWTH. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ANGIOGRAM AND BILATERAL LIMB COMPONENT BALLOONING, BUT THE PROCEDURE DID NOT RESOLVE THE ANEURYSM, AND NO FURTHER INTERVENTIONS WERE PERFORMED AT THAT TIME. A SUBSEQUENT CT SCAN ON (B)(6) 2026, SHOWED AN ADDITIONAL 0.5 CM OF GROWTH. ON (B)(6) 2026, THE PATIENT HAD AN INTERVENTION IN WHICH A GORE EXCLUDER WAS IMPLANTED TO RESOLVE THE ISSUE. DURING THE IMPLANT PROCEDURE, THE DEVICE IFU WAS FOLLOWED, AND THE DEVICE FUNCTIONED AS EXPECTED WHILE FOLLOWING THE IFU. THE ENDOLEAK WAS DISCOVERED ON THE FINAL ANGIOGRAM DURING THE DEPLOYMENT PROCEDURE. THERE WERE NO ADVERSE EVENTS, BUT THE PATIENT WAS AT RISK FOR PENDING RUPTURE. THE PATIENT OUTCOME WAS A SUCCESSFUL RE-INTERVENTION. NO PART OF THE PROCEDURE WAS PERFORMED OFF-LABEL OR OUTSIDE THE PATIENT SELECTION CRITERIA. THERE WERE NO DIFFICULTIES EXPERIENCED DURING DEPLOYMENT. THE PATIENT¿S ANAT

  Patient problems: Clinical Endoleak

  MAUDE report 24335292 ↗
• InjuryFeb 10, 2026Fluid/Blood Leak; Material Split, Cut or Torn

  SUSPECTED FABRIC TEAR AT CROTCH OF GRAFT:DURING ORIGINAL IMPLANT ((b)(6) 2025), AN ENDOLOEAK WAS OBSERVED BUT THE CAUSE HAD NOT BEEN CONFIRMED.(b)(6) 2025 - A FOLLOW UP CT SHOWED THAT THE ANEURYSM GREW 0.5 CM.(b)(6) 2025 - AN ADDITIONAL FOLLOW UP CT SHOWED THAT THE ANEURYSM GREW AN ADDITIONAL 1.0 CM.(b)(6) 2025 - THE PATIENT WAS TAKEN IN FOR AN ANGIOGRAM AND BILATERAL LIMB COMPONENT BALLOONING. IT DID NOT RESOLVE THE ANEURYSM. THEY DID NOT DO ANYTHING ELSE.(b)(6) 2026 - ANOTHER CT SHOWED AN ADDITIONAL 0.5 CM OF GROWTH.(b)(6) 2026 - THE PATIENT HAD AN INTERVENTION THAT PUT IN A GORE EXCLUDER TO RESOLVE THE ISSUE.ADDITIONAL INFORMATION RECEIVED:DURING THE IMPLANT PROCEDURE, THE DEVICE IFU WAS FOLLOWED, AND THE DEVICE FUNCTIONED AS EXPECTED WHILE FOLLOWING THE IFU. ENDOLEAK WAS DISCOVRED ON THE FINAL ANGIOGRAM DURING DEPLOYMENT PROCEDURE.THERE WERE NO ADVERSE EVENTS, BUT THE PATIENT WAS AT RISK FOR PENDING RUPTURE.THE PATIENT OUTCOME WAS SUCCESSFUL RE-INTERVENTION.NO PART OF THE PROCEDURE WAS PERFORMED OFF-LABEL OR OUT OF THE PATIENT SELECTION CRITERIA.NO DIFFICULTY WAS EXPERIENCED DURING DEPLOYMENT.THE PATIENT'S ANATOMY WAS A LITTLE TORTUOUS, BUT NOT BAD.THE PHYSICIAN THINKS A FABRIC

  Patient problems: Clinical Endoleak

  MAUDE report 24310803 ↗
• InjuryOct 1, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  FOLLOWING THE PROCEDURE FOR IMPLANTATION, THERE WAS A LEAK AT THE DISTAL EDGE OF THE OVERLAP BETWEEN THE TWO DEVICES ON COMPLETION ANGIOGRAM. THE SOURCE OF THE LEAK COULD NOT BE DETERMINED. THE PHYSICIAN IMPLANTED TWO ADDITIONAL COVERED STENTS EXTENDING SLIGHTLY ABOVE THE FLOW DIVIDER AND POST DILATED THEM. ANOTHER ANGIOGRAM FOLLOWING THIS SHOWED THE LEAK TO BE REPAIRED BUT THE EXACT SOURCE OF THE LEAK WAS NOT IDENTIFIED.

  Patient problems: No Code Available

  MAUDE report 9139180 ↗
• InjurySep 18, 2019Leak/Splash

  FOLLOWING THE PROCEDURE FOR IMPLANTATION, THERE WAS A LEAK AT THE DISTAL EDGE OF THE OVERLAP BETWEEN THE TWO DEVICES ON COMPLETION ANGIOGRAM. THE SOURCE OF THE LEAK COULD NOT BE DETERMINED. THE PHYSICIAN IMPLANTED TWO ADDITIONAL COVERED STENTS EXTENDING SLIGHTLY ABOVE THE FLOW DIVIDER AND POST DILATED THEM. ANOTHER ANGIOGRAM FOLLOWING THIS SHOWED THE LEAK TO BE REPAIRED BUT THE EXACT SOURCE OF THE LEAK WAS NOT IDENTIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 9084244 ↗
• MalfunctionJun 29, 2015Mechanical Problem; Difficult to Remove

  DURING DEPLOYMENT OF A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY INTO THE RIGHT COMMON ILIAC ARTERY FOR THE TREATMENT OF ILIAC OCCLUSION, THE BLACK TRIGGER WIRE MECHANISM GOT STUCK AND WOULDN'T COME OUT. THE USER TRIED TWISTING IT WITHOUT SUCCESS. THEN PLIERS WERE USED TO PULL THE WIRES OUT. THE WIRES CAME OUT EASILY. THE WHITE TRIGGER WIRE COULDN'T BE REMOVED BECAUSE THE BLACK TRIGGER WIRE MECHANISM WAS STUCK ON THE DELIVERY SYSTEM. THIS WIRE WAS ALSO PULLED OUT WITH PLIERS. THE CASE ENDED UP GOING AS PLANNED FOLLOWING THIS. THE DEVICE WAS SUCCESSFULLY DEPLOYED AND REMAINS IN THE PATIENT AS INTENDED. THE PATIENT DID NOT REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE, HOWEVER IT DID ADD APPROXIMATELY 40 MINUTES TO THE PROCEDURE TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 4886693 ↗

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-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-3132-2011 · Apr 15, 2011 · Terminated
  Cook Medical, Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-96-ZT, REF G48413, 18 Fr ID/ 7.1 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-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-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-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-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-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-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-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-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-3152-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-73-ZT, REF G48476, 16Fr ID/ 6.0 mm OD, Sterile.
• 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-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-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.