GORE EXCLUDER AAA Endoprosthesis PXC161200Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132609987), received between Sep 5, 2018 and Mar 10, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  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) 2025, A REINTERVENTION WAS PERFORMED FOR AN UNKNOWN REASON. AN ADDITIONAL CONTRALATERAL LEG WAS IMPLANTED DISTAL TO THE PREVIOUS DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 24555526 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. ON AN UNKNOWN DATE AT POSTOPERATIVE FOLLOW-UP, A TYPE I ENDOLEAK WAS IDENTIFIED AT THE DISTAL LEFT SIDE. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. TO ADDRESS THE DISTAL TYPE I ENDOLEAK ON THE LEFT SIDE, THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS EXTENDED TO THE LEFT EXTERNAL ILIAC ARTERY. ON THE RIGHT SIDE, AS A PREVENTIVE MEASURE, AN ADDITIONAL STENT GRAFTS (IBE) WERE IMPLANTED AT THE DISTAL RIGHT SIDE. THE PROCEDURE WAS COMPLETED WITH NO EVIDENCE OF ENDOLEAK.

  Patient problems: Insufficient Information

  MAUDE report 24555376 ↗
• InjurySep 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR ABDOMINAL AORTIC ANEURYSM. NON-GORE BARE METAL STENTS (LUMINEXX) WERE IMPLANTED TO RELINE BILATERAL LEGS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED THAT BILATERAL COMMON ILIAC BECAME ANEURYSMAL IN THE TREATED AREA. ENDOLEAKS WERE NOTED BILATERALLY. THE BILATERAL INTERNAL ILIAC ARTERIES WERE EMBOLIZED, AND ADDITIONAL STENT GRAFTS WERE DEPLOYED TO EXTEND THE DEVICE TO BILATERAL EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 12507557 ↗
• InjuryJul 21, 2021Migration; Migration

  ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, FOLLOW-UP EXAMINATION REPORTEDLY REVEALED A SUSPECTED TYPE IB ENDOLEAK SECONDARY TO PROXIMAL MIGRATION OF THE RIGHT LIMB. THE CAUSE OF THE MIGRATION AND SUSPECTED ENDOLEAK WAS NOT REPORTED. IT WAS UNKNOWN WHETHER ANEURYSM ENLARGEMENT WAS PRESENT. ON (B)(6) 2021, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE WHEREBY AN ADDITIONAL STENT GRAFT WAS DEPLOYED TO EXTEND THE RIGHT LIMB DISTALLY. NO ENDOLEAK WAS OBSERVED ON FINAL PROCEDURAL ANGIOGRAPH. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 12203220 ↗
• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A LEFT COMMON ILIAC ARTERY ANEURYSM USING TWO GORE(R) EXCLUDER(R) CONTRALATERAL LEG COMPONENTS. ON (B)(6) 2021, THE PATIENT PRESENTED WITH ANEURYSMAL DILATATION OF THE LEFT ILIAC ARTERY. ON THE SAME DAY, THE PATIENT UNDERWENT A RE-INTERVENTION PROCEDURE WHEREBY COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY WAS PERFORMED, AND AN ADDITIONAL GORE(R) EXCLUDER(R) DEVICE WAS IMPLANTED TO EXTEND THE STENT GRAFT SYSTEM DISTALLY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11280143 ↗
• InjurySep 5, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2006, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, FOLLOW-UP CT IMAGING IDENTIFIED A DISTAL TYPE I ENDOLEAK WITH NO EVIDENCE OF ANEURYSM ENLARGEMENT. IT WAS REPORTED THE CAUSE OF THE ENDOLEAK IS UNKNOWN. ON (B)(6) 2018, AN INTERVENTION WAS PERFORMED TO REPAIR THE DISTAL TYPE I ENDOLEAK FOR DISTAL EXTENSION ON THE PXC1612000. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7846188 ↗

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)