GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261218Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132610617), received between Sep 26, 2018 and Jul 29, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 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 4 most recent of 4 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 15133402 ↗
• InjurySep 27, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, A FOLLOW-UP CT SHOWED ENDOLEAK OF UNDETERMINED ORIGIN AND A SIGNIFICANT ANEURYSM GROWTH FROM 75MM (MEASURED ON (B)(6) 2017 VIA ULTRASOUND) TO 95MM. NO REINTERVENTION IS CURRENTLY PLANNED.

  Patient problems: No Code Available

  MAUDE report 7913780 ↗
• InjurySep 27, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2017, A FOLLOW-UP ULTRASOUND SCAN DETERMINED SIGNIFICANT ANEURYSM GROWTH FROM 68 TO 75MM ALONG WITH A TYPE II ENDOLEAK ORIGINATING FROM THE RIGHT ILIOLUMBAR ARTERY. ON (B)(6) 2017, THE ENDOLEAK WAS SUCCESSFULLY TREATED BY COILING OF THE RIGHT ILIOLUMBAR ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7913633 ↗
• InjurySep 26, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2016, A FOLLOW-UP CT SCAN DETERMINED SIGNIFICANT ANEURYSM GROWTH FROM 62 TO 71MM ALONG WITH A TYPE II ENDOLEAK ORIGINATING FROM LUMBAR ARTERIES. ON (B)(6) 2016, THE ENDOLEAK WAS SUCCESSFULLY TREATED WITH EMBOLIZATION. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7909126 ↗

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