GORE EXCLUDER AAA Endoprosthesis PXC231000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132618248), received between Jul 29, 2022 and May 8, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, A PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PHYSICIAN USED A FLARED LIMB ON THE 23 MM CONTRALATERAL LEG. ON (B)(6) 2025, THE PATIENT WAS TREATED FOR A TYPE 1B ENDOLEAK ON THE CONTRALATERAL LEG. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS PLACED INTO THE CONTRALATERAL LEG, AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS INSERTED FROM THE ARM AND DEPLOYED IN THE INTERNAL ILIAC ARTERY. THE PROCEDURE WAS SUCCESSFUL. THE PHYSICIAN REPORTED THAT HE BELIEVED THAT THE ILIAC ARTERY HAD WIDENED OVER TIME, LEADING TO THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 21986408 ↗
• InjuryJul 29, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING THREE GORE® EXCLUDER® AAA ENDOPROSTHESES (AAA). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURED RIGHT COMMON ILIAC ANEURYSM AND A DISTAL TYPE 1B ENDOLEAK AND UNDERWENT TREATMENT UTILIZING TWO ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES AND COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 15133513 ↗

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)