GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261412Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132610624), received between Jun 6, 2019 and Dec 6, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 54MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6), 2014. ON MARCH 4, 2015, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WHICH DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION MEASURED 51MM. ON FEBRUARY 8, 2022, THE PATIENT UNDERWENT FOLLOW-UP ULTRASOUND WHICH DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION MEASURED 49MM AND A TYPE II ENDOLEAK, NOT RELATED TO DEVICE OR PROCEDURE. ON OCTOBER 25, 2023, THE PATIENT UNDERWENT FOLLOW-UP ULTRASOUND WHICH DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION MEASURED 56MM. ON (B)(6), 2023, THE PATIENT UNDERWENT REINTERVENTION THIS DATE AND EMBOLIZATION A LUMBAR ARTERY THE ENDOLEAK WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED TO HOME ON (B)(6) 2023. EMBOLIZATION RESOLVED THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 18276854 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED ON (B)(6) 2013, WITH A ABDOMINAL AORTIC ANEURYSM (DIAMETER 59 MM) AND BILATERAL COMMON ILIAC ANEURYSMS THAT WERE TREATED WITH GORE® EXCLUDER® AAA AND ENDOPROSTHESES AND GORE® EXCLUDER® ILIAC BRANCH (IBE) ENDOPROSTHESES. ON (B)(6) 2014, A TYPE II ENDOLEAK WAS IDENTIFIED. THE PATIENT WAS MONITORED THE FOLLOWING YEARS AND CONTINUOUS GROWTH TO 82 MM WAS VISIBLE. THE ENDOLEAK WAS SUCCESSFULLY TREATED WITH COILING ON (B)(6) 2020. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10625332 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019, AN ANEURYSM OF THE LEFT COMMON ILIAC ARTERY WAS IDENTIFIED. THE ANEURYSM WAS TREATED WITH AN EXTENSION OF THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (RLT) ON (B)(6) 2020. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9738063 ↗
• InjuryJun 6, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE EXCLUDER AAA ENDOPROSTHESIS. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE HOSPITAL WITH LOWER EXTREMITY PAIN. COMPUTED TOMOGRAPHY REVEALED THAT THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS COMPRESSED DUE TO A PREVIOUSLY UNDIAGNOSED THORACIC AORTIC DISSECTION. THE FALSE LUMEN EXTENDED INTO THE ABDOMINAL AORTA AND COMPRESSED THE TRUE LUMEN. THE PHYSICIAN THEREFORE IMPLANTED A GORE TAG THORACIC ENDOPROSTHESIS (TGU343415) TO TREAT THE DISSECTION. THE FALSE LUMEN WAS CLOSED, AND PERFUSION WAS RESTORED TO THE TRUE LUMEN, AND THE TRUNK-IPSILATERAL LEG COMPONENT FULLY EXPANDED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 8676208 ↗

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)