Zenith G32592Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002325927), received between Mar 11, 2020 and Oct 26, 2020 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (1 report).

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

• DeathOct 26, 2020Structural Problem

  A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT A ZENITH FENESTRATED GRAFT PLACEMENT FOR A ABDOMINAL AORTIC ANEURYSM IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT WAS USED. THE CASE WENT AS STANDARD. IN THE RIGHT ILIAC LIMB THE PHYSICIAN USED A GORE GRAFT AS INITIALLY PLANNED. AFTER PLACED THE STENT LOOKED LIKE IT WAS NARROWED SO THE PHYSICIAN PUT DOWN KISSING STENTS AND BALLOONED AT THE NARROWING. THE BALLOON WAS A BARD BALLOON AND USED 14MM ON THE RIGHT AND USED 12MM ON THE LEFT. AT THIS TIME THE PATIENT BLOOD PRESSURE STARTED TO DROP. THE PHYSICIAN REALIZED RUPTURED THE AORTA WHEN BALLOONED. A CODA BALLOON WAS PUT DOWN AND SLOWED THE LEAK. PHYSICIAN DID AN ANGIOGRAM AND SAW CONTRAST LEAKING AT THE BIFURCATED AREA. THE PHYSICIAN PLACED ANOTHER GORE GRAFT DOWN TO THE FENESTRATED TO REALIGN THE LEG AND SEAL IT OFF. JUST UNDER THE RENAL STENTS ANOTHER GORE GRAFT WAS PLACED TO RE-STENT LOWEST RIGHT RENAL TO REASSURE NO LEAKING AROUND THERE. THE PATIENT WAS GIVEN A UNIT OF BLOOD AND WOULD STABILIZE, THEN BLOOD PRESSURE WOULD DROP AND PATIENT WAS GIVEN ANOTHER UNIT OF BLOOD TO STABILIZE; WAS DONE DURING PROCEDURE TO KEEP PATIENT STABILIZED. THE DISTRICT MANAGER DUE TO SCHEDULE LEFT

  Patient problems: Death; Rupture

  MAUDE report 10734485 ↗
• DeathOct 15, 2020Material Split, Cut or Torn; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn

  A 78 YEAR OLD FEMALE PATIENT UNDERWENT A ZENITH FENESTRATED GRAFT PLACEMENT FOR A ABDOMINAL AORTIC ANEURYSM IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT WAS USED. THE CASE WENT AS STANDARD. IN THE RIGHT ILIAC LIMB THE PHYSICIAN USED A GORE GRAFT AS INITIALLY PLANNED. AFTER PLACED THE STENT LOOKED LIKE IT WAS NARROWED SO THE PHYSICIAN PUT DOWN KISSING STENTS AND BALLOONED AT THE NARROWING. THE BALLOON WAS A BARD BALLOON AND USED 14MM ON THE RIGHT AND USED 12MM ON THE LEFT. AT THIS TIME THE PATIENT BLOOD PRESSURE STARTED TO DROP. THE PHYSICIAN REALIZED RUPTURED THE AORTA WHEN BALLOONED. A CODA BALLOON WAS PUT DOWN AND SLOWED THE LEAK. PHYSICIAN DID AN ANGIOGRAM AND SAW CONTRAST LEAKING AT THE BIFURCATED AREA. THE PHYSICIAN PLACED ANOTHER GORE GRAFT DOWN TO THE FENESTRATED TO REALIGN THE LEG AND SEAL IT OFF. JUST UNDER THE RENAL STENTS ANOTHER GORE GRAFT WAS PLACED TO RE-STENT LOWEST RIGHT RENAL TO REASSURE NO LEAKING AROUND THERE. THE PATIENT WAS GIVEN A UNIT OF BLOOD AND WOULD STABILIZE, THEN BLOOD PRESSURE WOULD DROP AND PATIENT WAS GIVEN ANOTHER UNIT OF BLOOD TO STABILIZE; WAS DONE DURING PROCEDURE TO KEEP PATIENT STABILIZED. THE DISTRICT MANAGER DUE TO SCHEDULE LEFT DUR

  Patient problems: Death; Rupture

  MAUDE report 10681898 ↗
• InjuryMar 12, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A PATIENT WITH A PRE-EXISTING ENDOGRAFT PLACED AT ANOTHER FACILITY HAD COME IN WITH A TOTAL LIMB OCCLUSION DUE TO THROMBUS. PHYSICIAN LYSED THROMBUS AND STENTED ILIAC LIMB. PATIENT IS DOING WELL. THE LIMB OCCLUSION CAUSED THE PATIENT TO BE SYMPTOMATIC. ON THE CONTRALATERAL SIDE.

  Patient problems: Occlusion

  MAUDE report 9826144 ↗
• InjuryMar 11, 2020Coagulation in Device or Device Ingredient

  A PATIENT WITH A PRE-EXISTING ENDOGRAFT PLACED AT ANOTHER FACILITY HAD COME IN WITH A TOTAL LIMB OCCLUSION DUE TO THROMBUS. PHYSICIAN LYSED THROMBUS AND STENTED ILIAC LIMB. PATIENT IS DOING WELL. THE LIMB OCCLUSION CAUSED THE PATIENT TO BE SYMPTOMATIC.

  Patient problems: Occlusion

  MAUDE report 9820969 ↗

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-3135-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-30-82-ZT, REF G48422, 20 Fr ID/ 7.7 mm OD
• 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-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-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-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-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-3139-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-10-71-ZT, REF G48444, 14 Fr ID/ 5.3 mm OD, Sterile.
• Z-3133-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Main Body, REF TFFB-26-125-ZT, REF G48415, 18 Fr ID/ 7.1 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-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-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-3141-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-14-56-ZT, REF G48455, 16Fr ID/ 6.0 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-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.

…and 96 more.