Zenith G32550Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002325507), received between Nov 7, 2016 and Feb 14, 2022 — classified as 2 deaths, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2022Break; Difficult to Remove; Physical Resistance/Sticking

  THE DEVICE WAS ORIENTED ON TOP OF THE PATIENT WITH ALL MARKERS SUCCESSFULLY IDENTIFIED. THE GRAFT WAS LOADED AND ADVANCED WITH NO ISSUES. THEN, DUE TO ANATOMICAL TORTUOSITY, THE DEVICE BECAME INVERTED. THEY PROCEEDED TO CORRECT THE INVERSION BY ROTATING THE GRAFT, CAUSING TENSION AND PRESSURE ON THE TRIGGER WIRES AND GRAFT. THE PROCEDURE CONTINUED PER THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE. THERE WAS NO ISSUE UNSHEATHING AND NO ISSUE CANNULATING THE RENALS THROUGH THE FENESTRATIONS. WHEN IT WAS TIME TO FINISH DEPLOYMENT OF THE GRAFT AND REMOVE THE TRIGGER WIRES, THE CORKSCREW TENSION ON THE DELIVERY SYSTEM AND TRIGGER WIRES MADE IT VERY DIFFICULT TO REMOVE THE FIRST TWO TRIGGER WIRES. WHEN ATTEMPTING TO REMOVE THE THIRD AND FINAL DISTAL TRIGGER WIRE; THE WIRE BROKE AT THE POINT OF THE ATTACHMENT TO THE TRIGGER WIRE RELEASE MECHANISM. AT THIS POINT THE GRAFT WAS STILL ATTACHED VIA THE TRIGGER WIRE DISTALLY. THEY WERE UNABLE TO LOCATE, GRAB OR VISUALIZE THE OTHER END OF THE TRIGGER WIRE NEAR THE DELIVERY HANDLE. THE WHITE DELIVERY HANDLE COMPONENTS WERE DISASSEMBLED; AND THEY ATTACHED A HEMOSTAT TO THE HANDLE END OF THE TRIGGER WIRE AND CAREFULLY PULLED, WITH MUCH FO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529750 ↗
• InjuryJun 4, 2020Material Separation; Material Separation

  THE PROXIMAL GRAFT AND THE DISTAL GRAFT SEPARATED CREATING A TYPE 3 ENDOLEAK. SURGICAL INTERVENTION WAS REQUIRED. THE DISTAL FENESTRATED COMPONENT LOST ITS OVERLAP WITH THE PROXIMAL FENESTRATED COMPONENT. THE DISTAL COMPONENT MIGRATED DOWN INTO THE ANEURYSM AT A DIFFICULT ANGLE POSTERIORLY. ALSO, THE RIGHT AND LEFT ILIAC LIMBS LOST SEAL WITHIN THE COMMON ILIACS AND MIGRATED UP INTO THE ANEURYSM. THE DISTAL FENESTRATED GRAFT AND LIMBS FOLDED IN THE ANEURYSM MAKING REINTERVENTION DIFFICULT. PHYSICIAN ACCESSED THE AXILLARY ARTERY AND PUT A 8FR SHEATH DOWN INTO THE AORTA. HE STENTED THE SUPERIOR MESENTERIC ARTERY WITH A GORE 8X29 VBX AND STENTED THE LEFT RENAL ARTERY WITH A GORE 6X29 VBX. HE THEN DROVE A WIRE DOWN INTO THE PROXIMAL FENENSTRATED GRAFT. HE WAS ABLE TO SNAKE THE WIRE INTO THE DISTAL GRAFT AND THROUGH THE LEFT ILIAC LIMB. THE PHYSICIAN ACCESSED BOTH FEMORAL ARTERIES AND THEN FROM THE LEFT SIDE SNARED THE WIRE FROM ABOVE. ONCE HE HAD WIRE ACCESS HE EXCHANGED IT TO A STIFF WIRE WHICH HELPED STRAIGHTEN OUT THE FOLDED GRAFT. HE THEN ACCESSED THE PATIENTS RIGHT FEMORAL ARTERY WITH A WIRE AND WAS ABLE TO GET ACCESS INTO THE AORTA FROM BOTH SIDES. HE DECIDED TO RELINE THE GRAFT W

  Patient problems: No Code Available

  MAUDE report 10119796 ↗
• InjuryJun 1, 2020Migration; Leak/Splash; Migration or Expulsion of Device; Migration

  THE PROXIMAL GRAFT AND THE DISTAL GRAFT SEPARATED CREATING A TYPE 3 ENDOLEAK. SURGICAL INTERVENTION WAS REQUIRED. THE DISTAL FENESTRATED COMPONENT LOST ITS OVERLAP WITH THE PROXIMAL FENESTRATED COMPONENT. THE DISTAL COMPONENT MIGRATED DOWN INTO THE ANEURYSM AT A DIFFICULT ANGLE POSTERIORLY. ALSO, THE RIGHT AND LEFT ILIAC LIMBS LOST SEAL WITHIN THE COMMON ILIACS AND MIGRATED UP INTO THE ANEURYSM. THE DISTAL FENESTRATED GRAFT AND LIMBS FOLDED IN THE ANEURYSM MAKING REINTERVENTION DIFFICULT. PHYSICIAN ACCESSED THE AXILLARY ARTERY AND PUT A 8FR SHEATH DOWN INTO THE AORTA. HE STENTED THE SUPERIOR MESENTERIC ARTERY WITH A GORE 8X29 VBX AND STENTED THE LEFT RENAL ARTERY WITH A GORE 6X29 VBX. HE THEN DROVE A WIRE DOWN INTO THE PROXIMAL FENESTRATED GRAFT. HE WAS ABLE TO SNAKE THE WIRE INTO THE DISTAL GRAFT AND THROUGH THE LEFT ILIAC LIMB. THE PHYSICIAN ACCESSED BOTH FEMORAL ARTERIES AND THEN FROM THE LEFT SIDE SNARED THE WIRE FROM ABOVE. ONCE HE HAD WIRE ACCESS HE EXCHANGED IT TO A STIFF WIRE WHICH HELPED STRAIGHTEN OUT THE FOLDED GRAFT. HE THEN ACCESSED THE PATIENTS RIGHT FEMORAL ARTERY WITH A WIRE AND WAS ABLE TO GET ACCESS INTO THE AORTA FROM BOTH SIDES. HE DECIDED TO RELINE THE GRAFT WI

  Patient problems: No Code Available

  MAUDE report 10107182 ↗
• DeathJan 14, 2020Detachment of Device or Device Component

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS VIA EMAILED COMPLAINT FORM FROM DISTRICT MANAGER: AN (B)(6) YEAR OLD MALE PATIENT UNDERWENT AN FEVAR ON THE AORTA ON (B)(6) 2019 IN WHICH A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, G32550, AND A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY, G32500, AND TWO 6X22MM ATRIUM ICAST STENTS WERE IMPLANTED ON (B)(6) 2019. AFTER (B)(6) 2019 THE ABDOMINAL ANEURYSM CONTINUED TO GROW AROUND THE FENESTRATED IMPLANT. THERE WAS SEPARATION OF THE ICAST RENAL STENT FROM THE PROXIMAL FENESTRATED GRAFT. ON (B)(6) 2019 THE PATIENT PRESENTED W/ AORTIC RUPTURE INCLUDING SEPARATION OF THE RIGHT RENAL STENT (6X22 ICAST) FROM THE PROXIMAL FENESTRATED GRAFT. ADDITIONAL IMPLANTS, THREE GORE VIABAHN STENTS WERE USED AS WELL AS A COOK ZDEG-P-38-79-PF-US & A ESBE-36-50-ZT & ZTA-P-40-117-W, WERE ADDED TO STOP THE HEMORRHAGE BUT DID NOT FIX THE RUPTURED AORTA. PATIENT EXPIRED ON (B)(6) 2019.

  Patient problems: Death

  MAUDE report 9588509 ↗
• DeathJan 13, 2020Detachment of Device or Device Component

  AN (B)(6) MALE PATIENT UNDERWENT A FENESTRATED ENDOVASCULAR AORTIC REPAIR ON THE AORTA ON THE (B)(6) 2019 IN WHICH A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY, AND A ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY, AND TWO 6X22MM ATRIUM ICAST STENTS WERE IMPLANTED. AFTER THE (B)(6) 2019 THE ABDOMINAL ANEURYSM CONTINUED TO GROW AROUND THE FENESTRATED IMPLANT. THERE WAS SEPARATION OF THE ICAST RENAL STENT FROM THE PROXIMAL FENESTRATED GRAFT. ON THE (B)(6) 2019 THE PATIENT PRESENTED WITH AORTIC RUPTURE INCLUDING SEPARATION OF THE RIGHT RENAL STENT (6X22 ICAST) FROM THE PROXIMAL FENESTRATED GRAFT. ADDITIONAL IMPLANTS, THREE GORE VIABAHN STENTS WERE USED AS WELL AS A COOK ZDEG-P-38-79-PF-US & A ESBE-36-50-ZT & ZTA-P-40-117-W, WERE ADDED TO STOP THE HEMORRHAGE BUT DID NOT FIX THE RUPTURED AORTA. THE PATIENT EXPIRED ON THE (B)(6) 2019.

  Patient problems: Death; Unspecified Infection

  MAUDE report 9583143 ↗
• InjuryMay 17, 2018Device Operates Differently Than Expected

  THE PHYSICIAN DECIDED TO MODIFY THE GRAFT AND MAKE HIS OWN FENESTRATION PRIOR TO ATTEMPTED IMPLANT. THE DEVICE TOP CAP DID NOT PUSH OFF DURING THE PROCEDURE. THE PHYSICIAN HAD TO CONVERT TO OPEN REPAIR FOR ATTEMPTED EXPLANT. THE DELIVERY SYSTEM HAD TO STAY IN THE PATIENT WHEN GOING TO OPEN REPAIR.

  Patient problems: No Code Available

  MAUDE report 7524528 ↗
• MalfunctionNov 7, 2016Flaked; Device Packaging Compromised

  THE PHYSICIAN OPENED THE PACKAGE AND NOTICED THAT THE HYDROPHILIC COATING ON THE SHEATH WAS FLAKING OFF. HE WIPED DOWN THE COATING WITH SALINE AND TRIED REMOVE ALL THE FLAKINESS FROM THE DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6084552 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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.

…and 96 more.