Zenith G32533Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10827002325330), received between Mar 21, 2018 and Mar 11, 2022 — classified as 1 death, 7 injuries.

The most frequently reported specific device problem is “Positioning Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 11, 2022Material Rupture; Material Rupture

  3 YEARS POST IMPLANT, THE PATIENT CAME INTO THE ER WITH AN ABDOMINAL AORTIC RUPTURE. PATIENT UNDERWENT OPEN SURGERY WITH GRAFT EXPLANT AND AORTIC REPAIR. THREE DAYS LATER A WASH OUT WAS ALSO REQUIRED.

  Patient problems: Great Vessel Perforation

  MAUDE report 13739557 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem

  3 YEARS POST IMPLANT, THE PATIENT CAME INTO THE ER WITH AN ABDOMINAL AORTIC RUPTURE. PATIENT UNDERWENT OPEN SURGERY WITH GRAFT EXPLANT AND AORTIC REPAIR. THREE DAYS LATER A WASH OUT WAS ALSO REQUIRED.

  Patient problems: Great Vessel Perforation; Renal Impairment; Ruptured Aneurysm

  MAUDE report 13657403 ↗
• InjuryJul 21, 2021Inadequacy of Device Shape and/or Size; Material Twisted/Bent; Inadequacy of Device Shape and/or Size

  THE PATIENT UNDERWENT A FENESTRATED ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE IN WHICH THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY WAS IMPLANTED. ON POST-OPERATION FOLLOW UP, THE IMAGING SHOWED THE SUPRA-RENAL EXPOSED STENTS HAVE TWISTED UP ON THEMSELVES. IT DID NOT APPEAR TO INTERRUPT BLOOD FLOW. AT THE TIME OF THE COMPLAINT REPORT THE PHYSICIAN WAS NOT PLANNING A FOLLOW UP PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200711 ↗
• InjuryMay 17, 2020No Flow

  IT WAS REPORTED THAT A 67 YEAR OLD MALE PATIENT ON (B)(6) 2019 UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE IN WHICH TWO ICAST STENTS WERE IMPLANTED. ON (B)(6) 2020 THE PATIENT PRESENTED BACK TO THE HOSPITAL AS BOTH RENAL ARTERIES WERE OCCLUDED AND UNDERWENT A RENAL INTERVENTION. A RENALGRAM WAS PERFORMED IN THE O.R. THE PHYSICIAN TRIED TO GET A WIRE AND CATHETER TO TRACK IN THE RENALS BUT WAS UNSUCCESSFUL IN BOTH AS DUE TO THROMBUS. IT HAS BEEN FURTHER REPORTED THAT THE PATIENT HAS NO FLOW INTO HIS KIDNEYS AND IS NOW IN COMPLETE RENAL FAILURE; PT IS NOW ON DIALYSIS AND IS SEEKING TO BE ON A KIDNEY TRANSPLANT LIST. THE PHYSICIAN FEELS THE ZFEN PROXIMAL DEVICE MAY HAVE SHIFTED BASED ON PRE-IMPLANT RENAL POSITION VS. NEW RENAL ARTERY POSITION OR ENTIRE DEVICE MOVED CAUSING STENT COMPRESSION

  Patient problems: Occlusion; Renal Failure

  MAUDE report 10064103 ↗
• InjuryMay 11, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A (B)(6) YEAR OLD MALE PATIENT ON (B)(6) 2019 UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR PROCEDURE IN WHICH TWO ICAST STENTS WERE IMPLANTED. ON (B)(6) 2020 THE PATIENT PRESENTED BACK TO THE HOSPITAL AS BOTH RENAL ARTERIES WERE OCCLUDED AND UNDERWENT A RENAL INTERVENTION. A RENALGRAM WAS PERFORMED IN THE OPERATING ROOM THE PHYSICIAN TRIED TO GET A WIRE AND CATHETER TO TRACK IN THE RENALS BUT WAS UNSUCCESSFUL IN BOTH AS DUE TO THROMBUS. IT HAS BEEN FURTHER REPORTED THAT THE PATIENT HAS NO FLOW INTO HIS KIDNEYS AND IS NOW IN COMPLETE RENAL FAILURE; PT IS NOW ON DIALYSIS AND IS SEEKING TO BE ON A KIDNEY TRANSPLANT LIST. THE PHYSICIAN FEELS THE ZFEN PROXIMAL DEVICE MAY HAVE SHIFTED BASED ON PRE-IMPLANT RENAL POSITION VS. NEW RENAL ARTERY POSITION OR ENTIRE DEVICE MOVED CAUSING STENT COMPRESSION.

  Patient problems: No Code Available; Occlusion; Renal Failure

  MAUDE report 10043569 ↗
• InjuryOct 4, 2019Fluid/Blood Leak

  PATIENT UNDERWENT A AAA REPAIR ON (B)(6) 2019 FOR A AAA IN WHICH THE FOLLOWING DEVICES WERE IMPLANTED: ZFEN-P-2-30-94-R. ZFEN-D-12-28-76-C, ZSLE-30-39-ZT (LEFT ILIAC), ZSLE-20-74-ZT (RIGHT ILIAC), AND ESBE-26-39-ZT. A SMALL ENDOLEAK WAS NOTED AND THE PHYSICIAN PLACED THE ESBE DEVICE WHICH RESOLVED THE LEAK. THE PATIENT RETURNED FOR SCHEDULED FOLLOW UP ON (B)(6) 2019 AND AN ENDOLEAK, POSSIBLE TYPE II, AND THE PHYSICIANS PARTNER SUGGESTED POSSIBLE TYPE II ENDOLEAK VIA ANGIOGRAM. A FOLLOW UP PROCEDURE TO ADDRESS THE LEAK WAS SCHEDULED FOR (B)(6) 2019. ON FRIDAY (B)(6) 2019, THE FOLLOW UP PROCEDURE TO DETERMINE WHERE THE ENDOLEAK WAS LOCATED COULD NOT BE DETERMINED. AS THE PHYSICIAN NOTED THIS WAS A BRISK ENDOLEAK IT WAS DECIDED TO RE-ALIGN THE DEVICE AT THE BIFURCATION. PHYSICIAN DID IMAGES WITH CODA BALLOON TO SEE IF OVERLAP LEAKED BUT WAS UNSUCCESSFUL IN DETERMINING. A ZSLE-20-56, LOT# 9670741, WAS DEPLOYED IN THE LEFT ILIAC BUT DID NOT STOP THE LEAK. THE PHYSICIAN THEN DEPLOYED AN ESBE-30-39-ZT- LOT# 9888654, A ZSLE-20-90-ZT- LOT# 9835111 (RIGHT ILIAC) AND A ZSLE-20-74-ZT- LOT# 9748250 (LEFT ILIAC). DID A KISSING COTA BALLOON AND A FINAL ANGIOGRAM SHOWED NO LEAK. THE PATIENT WAS DI

  Patient problems: No Code Available

  MAUDE report 9157863 ↗
• InjurySep 29, 2019Positioning Problem

  PATIENT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2019 FOR AN ABDOMINAL AORTIC ANEURYSM IN WHICH THE FOLLOWING DEVICES WERE IMPLANTED: ZFEN-P-2-30-94-R, ZFEN-D-12-28-76-C, ZSLE-30-39-ZT (LEFT ILIAC), ZSLE-20-74-ZT (RIGHT ILIAC), AND ESBE-26-39-ZT. A SMALL ENDOLEAK WAS NOTED AND THE PHYSICIAN PLACED THE ESBE DEVICE WHICH RESOLVED THE LEAK. THE PATIENT RETURNED FOR SCHEDULED FOLLOW UP ON (B)(6) 2019 AND AN ENDOLEAK, POSSIBLE TYPE II, AND THE PHYSICIANS PARTNER SUGGESTED POSSIBLE TYPE II ENDOLEAK VIA ANGIOGRAM. A FOLLOW UP PROCEDURE TO ADDRESS THE LEAK WAS SCHEDULED FOR (B)(6) 2019. ON FRIDAY, (B)(6) 2019, THE FOLLOW UP PROCEDURE TO DETERMINE WHERE THE ENDOLEAK WAS LOCATED COULD NOT BE DETERMINED. AS THE PHYSICIAN NOTED THIS WAS A BRISK ENDOLEAK IT WAS DECIDED TO RE-ALIGN THE DEVICE AT THE BIFURCATION. PHYSICIAN DID IMAGES WITH CODA BALLOON TO SEE IF OVERLAP LEAKED BUT WAS UNSUCCESSFUL IN DETERMINING. A ZSLE-20-56, LOT# 9670741, WAS DEPLOYED IN THE LEFT ILIAC BUT DID NOT STOP THE LEAK. THE PHYSICIAN THEN DEPLOYED AN ESBE-30-39-ZT- LOT# 9888654, A ZSLE-20-90-ZT- LOT# 9835111 (RIGHT ILIAC) AND A ZSLE-20-74-ZT- LOT# 9748250 (LEFT ILIAC). DID A KISSING COTA BALLOON AND A FIN

  Patient problems: Aneurysm

  MAUDE report 9132545 ↗
• DeathMar 21, 2018Positioning Problem

  THE DEVICE WAS PLACED SUCCESSFULLY. WHILE CANNULATING, THE WIRE (BOSTON SCIENTIFIC WIRE) WENT OUT TOO FAR INTO THE RENAL ARTERY AND PERFORATED THE RENAL ARTERY. THE DEVICE USER ATTEMPTED TO CONTROL THE BLEEDING AND BELIEVED THE PATIENT WAS HEMODYNAMICALLY STABLE. THE PROCEDURE CONTINUED AND 3 ADDITIONAL GRAFTS WERE PLACED SUCCESSFULLY.

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 7360275 ↗

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-3149-2011 · Apr 15, 2011 · Terminated
  Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 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-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-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-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-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-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-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-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-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-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-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-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.