GORE EXCLUDER AAA Endoprosthesis PXT231412Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132610136), received between Nov 7, 2018 and Mar 10, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 reports).

2 other recalls cover devices cleared under the same FDA submission (P020004); 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 10, 2026Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED FOR A TYPE IA ENDOLEAK FOUND ON A FOLLOW-UP EXAMINATION. GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WAS ADDITIONALLY IMPLANTED WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE).

  Patient problems: Clinical Endoleak

  MAUDE report 24555427 ↗
• InjuryNov 11, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR DISSECTED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED FOR A TYPE IA ENDOLEAK WHICH HAD BEEN FOUND DURING A REGULAR FOLLOW-UP. TWO ADDITIONAL AORTIC EXTENDERS WERE IMPLANTED WITH A CHIMNEY TECHNIQUE FOR THE BILATERAL RENAL ARTERIES. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23528739 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. 1X TRUNK IPSILATERAL LEG AND TOTAL 4X CONTRALATERAL LEGS WERE IMPLANTED, EXTENDING TO BOTH COMMON ILIAC ARTERIES. ON AN UNKNOWN DATE, EXPANSION OF BOTH COMMON ILIAC ARTERIES WAS OBSERVED. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. BOTH INTERNAL ILIAC ARTERIES WERE COIL-EMBOLIZED, AND ADDITIONAL STENT GRAFTS WERE PLACED IN EACH EXTERNAL ILIAC ARTERIES. FURTHERMORE, A BIRD-BEAK WAS OBSERVED AT THE PROXIMAL END OF THE TRUNK IPSILATERAL LEG. ALTHOUGH NO ENDOLEAK WAS OBSERVED, AN ADDITIONAL STENT GRAFT WAS PLACED PROXIMALLY AS A PREVENTIVE MEASURE. THE PHYSICIAN¿S COMMENT: ¿AS WE DO NOT HAVE SURGICAL RECORDS, IT IS UNCLEAR WHETHER THE INITIAL PLACEMENT OF STENT GRAFTS WAS SUBOPTIMAL OR IF THERE WAS AN ERROR IN SIZE SELECTION. ALTHOUGH MORE THAN 16 YEARS HAD PASSED SINCE THE INITIAL PLACEMENT, NO DAMAGE OR DETERIORATION OF THE DEVICE WAS OBSERVED.¿

  Patient problems: Insufficient Information

  MAUDE report 21304023 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE:ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSM.ON AN UNKNOWN DATE, AT FOLLOW-UP EXAMINATION, ENLARGEMENT OF THE ANEURYSM DIAMETER WAS CONFIRMED.ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION. AN ADDITIONAL STENT GRAFT WAS DEPLOYED TO EXTEND THE RIGHT LIMB TO THE EXTERNAL ILIAC ARTERY, AND THE INTERNAL ILIAC ARTERY WAS EMBOLIZED. ANEURYSMORRHAPHY WAS PERFORMED ALSO. THE CAUSE OF THE ANEURYSM ENLARGEMENT WAS NOT REPORTED.

  Patient problems: Aneurysm expansion

  MAUDE report 18504859 ↗
• InjuryNov 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2020, A RE-INTERVENTION WAS PERFORMED. AN AORTIC EXTENDER COMPONENT WAS PLACED TO PREVENT A PROXIMAL TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ACCORDING TO THE PHYSICIAN, IT WAS DECIDED TO ADD THE DEVICE TO PREVENT THE FUTURE PROBLEMS BECAUSE THE ENLARGEMENT (APPROXIMATELY 3MM) OF THE PROXIMAL SIDE OF THE AORTA WAS OBSERVED ON THE CT IMAGING. THERE WAS NO INFORMATION PROVIDED REGARDING THE CAUSE OF ENLARGEMENT. ADDITIONALLY, THE PHYSICIAN ALSO WANTED TO AVOID PERFORMING ANY ADDITIONAL PROCEDURE IN THE FUTURE BECAUSE THE PATIENT IS QUITE OLD.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 10900365 ↗
• InjurySep 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON OR ABOUT (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE INTRAOPERATIVE IMAGING REVEALED A TYPE II ENDOLEAK. THE PHYSICIAN ELECTED TO MONITOR THE ENDOLEAK, AND THE PROCEDURE WAS COMPLETED. AT TIME OF THE PROCEDURE, THE ANEURYSM MEASURED APPROXIMATELY 30 MM. ON (B)(6) 2020, FOLLOW UP IMAGING REVEALED ANEURYSM ENLARGEMENT (THE ANEURYSM DIAMETER WAS APPROXIMATELY 40 MM) AND PROXIMAL TYPE I ENDOLEAK. A RE-INTERVENTION IS PLANNED TO PLACE ADDITIONAL STENT GRAFT AT PROXIMAL. IT WAS REPORTED THAT THE TRUNK-IPSILATERAL LEG COMPONENT WAS PLACED AT A SEVERE PROXIMAL ANGLE, AND THE LEAK MIGHT HAVE BEEN OCCURRED FROM RIGHT SIDE OF PROXIMAL.

  Patient problems: Aneurysm

  MAUDE report 10528800 ↗
• InjuryJun 25, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2019, COMPUTED TOMOGRAPHIC IMAGES WERE READ THAT SHOWED AN APPARENT TYPE III DISCONNECT ENDOLEAK BETWEEN THE TRUNK-IPSILATERAL LEG COMPONENT AND THE CONTRALATERAL LEG COMPONENT. ON (B)(6) 2019, A REINTERVENTION OCCURRED WHEREBY ANOTHER CONTRALATERAL LEG COMPONENT (PLC161000) WAS IMPLANTED TO REPAIR THE TYPE III DISCONNECT ENDOLEAK. FINAL ANGIOGRAPHY CONFIRMED THE ENDOLEAK WAS RESOLVED. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8731190 ↗
• InjuryNov 7, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, IMAGING IDENTIFIED A DISTAL TYPE I ENDOLEAK WITH AN UNKNOWN AMOUNT OF ANEURYSM ENLARGEMENT. IT WAS REPORTED THE CAUSE OF THE ENDOLEAK WAS DISEASE PROGRESSION. ON (B)(6) 2018, A RE-INTERVENTION WAS PERFORMED TO TREAT THE DISTAL TYPE I ENDOLEAK WHEREBY A PLC231000 WAS IMPLANTED EXTENDING FROM THE EXISTING IPSILATERAL LEG.

  Patient problems: Aneurysm

  MAUDE report 8048940 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P020004. One submission often covers many models, so check the product and lot details in each record.

• Z-0995-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER AAA Endoprosthesis
• Z-0996-2020 · Jan 6, 2020 · Terminated
  GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)