GORE EXCLUDER AAA Endoprosthesis PXC231200Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132618231), received between Jul 29, 2022 and Jul 29, 2022 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• 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 15133884 ↗

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)