Zenith G32561Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002325613), received between Aug 19, 2018 and Sep 29, 2021 — classified as 6 injuries.

The most frequently reported specific device problem is “Material Separation” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2021Material Separation

  THE PATIENT WAS DISCOVERED UNCONSCIOUS AT HOME BY A FAMILY MEMBER AND WAS BROUGHT TO THE HOSPITAL WHERE AN IMAGING PROCEDURE WAS PERFORMED. IMAGING SHOWED THAT THE ANEURYSM SAC APPEARED TO BE ENLARGED AND COMPONENT SEPARATION. THE PATIENT HAS REFUSED FURTHER TREATMENT.

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

  MAUDE report 12545860 ↗
• InjurySep 15, 2021Material Separation; Migration; Migration

  THE PATIENT WAS DISCOVERED UNCONSCIOUS AT HOME BY A FAMILY MEMBER AND WAS BROUGHT TO THE HOSPITAL WHERE AN IMAGING PROCEDURE WAS PERFORMED. IMAGING SHOWED THAT THE ANEURYSM SAC APPEARED TO BE ENLARGED AND COMPONENT SEPARATION. THE PATIENT HAS REFUSED FURTHER TREATMENT.

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

  MAUDE report 12477885 ↗
• InjuryJan 8, 2020Detachment 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 16 DEC 19. 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: Aneurysm; Blood Loss

  MAUDE report 9565936 ↗
• 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. 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 9563494 ↗
• InjuryJan 10, 2019Patient-Device Incompatibility; Material Twisted/Bent

  THE INITIAL PROCEDURE WENT AS INTENDED. THE PATIENT RETURNED TO THE HOSPITAL COMPLAINING OF LEFT LEG WEAKNESS. DUPLEX DOPPLER WAS PERFORMED AND HIGH VELOCITY WAS NOTED IN THE EXTERNAL ILIAC ARTERY. THE PATIENT WAS BROUGHT IN FOR AN AORTAGRAM AND IT WAS CONFIRMED THAT THERE WAS A KINK IN THE IPSILATERAL LEG OF THE DEVICE. AN INTERVENTION WAS PERFORMED.

  Patient problems: Muscle Weakness/Atrophy; Weakness

  MAUDE report 8234034 ↗
• InjuryAug 19, 2018Leak/Splash; Material Separation; Failure to Align

  ON (B)(6) 2013, THE PATIENT RECEIVED A PROXIMAL COMPONENT, A DISTAL COMPONENT AND A SPIRAL Z ILIAC LEG. ONE 6 MM X 22 MM ATRIUM ICAST STENT WAS PLACED IN THE RIGHT RENAL ARTERY. ONE 6 X 22 MM ATRIUM ICAST STENT WAS PLACED IN THE LEFT RENAL ARTERY. THE IMPLANTING PHYSICIAN NOTED DIFFICULTY DEPLOYING THE FENESTRATION STENTS - THE LEFT RENAL FENESTRATION WAS NOT ALIGNED UPON DEPLOYMENT. AT THE CONCLUSION OF THE CASE, THE ENDOVASCULAR GRAFT AND BOTH FENESTRATED AND STENTED RENAL ARTERIES WERE PATENT. A PROXIMAL TYPE I ENDOLEAK WAS NOTED AT THE PROXIMAL LANDING ZONE BUT WAS NOT TREATED. A KINK WAS NOTED IN THE LEFT SPIRAL-Z LIMB. THE LIMB WAS REINFORCED WITH A 12 MM X 20 MM LIFESTAR STENT. THE PATIENT¿S ESTIMATED BLOOD LOSS WAS 800 CC AND THE PATIENT RECEIVED 1500 CC OF PACKED RED BLOOD CELLS (PRBCS) AND 250 CC OF FRESH FROZEN PLASMA (FFP) INTRA-OPERATIVELY. NO PATIENT-RELATED ADVERSE EVENTS WERE OBSERVED DURING THE PROCEDURE. CORE LAB REVIEW OF THE PROCEDURAL ANGIOGRAM REPORTED AN UNKNOWN TYPE ENDOLEAK. THREE STENT OVERLAP WAS NOTED BETWEEN THE PROXIMAL AND DISTAL GRAFTS. ONE STENT OVERLAP WAS NOTED BETWEEN THE DISTAL GRAFT AND THE LIMB COMPONENT. ON (B)(6) 2013, A POST-PROCEDURE CT SC

  Patient problems: Abdominal Pain; Anemia; Blood Loss; Fall; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7796275 ↗

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-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-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-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-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-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-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-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-3144-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-16-90-ZT, REF G48463, 16Fr ID/ 6.0 mm 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-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-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-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-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-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-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

…and 96 more.