GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT311417Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132610761), received between Sep 27, 2018 and Jul 31, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2011, PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISTAL ANEURYSM IN THE RIGHT LIMB UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. REPORTEDLY, PHYSICIAN EMBOLIZED THE RIGHT HYPOGASTRIC ARTERY AND EXTENDED INTO THE RIGHT EXTERNAL ILIAC ARTERY WITH A CONTRALATERAL LEG. THERE WAS NO ENDOLEAK SEEN ON THE CT SCANS PRIOR TO THE REINTERVENTION AND CAUSE OF THE ANEURYSM SIZE AND GROWTH IS UNKNOWN. PATIENT IS DOING OKAY AFTER THE PROCEDURE.

  Patient problems: Aneurysm expansion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22675295 ↗
• InjuryDec 14, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN ANEURYSM IN THE AORTA AN UNDERWENT TREATMENT UTILIZING TWO GORE® EXCLUDER® AAA ENDOPROSTHESES (AAA) (RMT311417/(B)(4) & PLC161400/(B)(4)). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT PRESENTED WITH A SUSPECTED TYPE 3 ENDOLEAK OF THE PREVIOUSLY IMPLANTED AAA DEVICES AND UNDERWENT REINTERVENTION UTILIZING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES (CXT). UPON DEPLOYMENT OF THE CXT DEVICE, THE DISTAL END OF THE DEVICE (MOST INFERIOR STENT ROW) WAS HUNG UP ON THE INNER WALL OF THE EXISTING 31MM AAA DEVICE, KEEPING IT FROM LAYING PARALLEL AND FULLY APPOSING THE WALL. AFTER BALLOONING, IT APPEARED THAT THE CTX DEVICE'S DISTAL STENT WAS BETTER APPOSED TO THE INNER WALL OF THE PREVIOUSLY PLACED AAA DEVICE. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY. THERE IS SOME DOUBT AS TO HOW STABLE THE DEVICE CATHETER WAS KEPT DURING DEPLOYMENT BY THE FELLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13005951 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY WHICH DETERMINED A PROXIMAL TYPE I ENDOLEAK REPORTED TO BE CAUSED BY A LACK OF SEAL AND APPOSITION OF THE GRAFT. THE PATIENT IS GOING TO BE REFERRED TO ANOTHER PHYSICIAN FOR A POSSIBLE OPEN SURGICAL PROCEDURE, AS THE PATIENT HAS A SHORT PROXIMAL NECK AND THE PHYSICIAN DOES NOT THINK EXTENDING PROXIMALLY WILL RESOLVE THE ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 11758223 ↗
• InjuryJun 25, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT PRESENTED WITH A 55 MM ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. FOLLOW-UP IMAGING SHOWED THAT THE ANEURYSM SIZE APPEARED TO BE STABLE UNTIL (B)(6) 2017 (52 MM). ANEURYSM GROWTH TO 60 MM WAS VISIBLE ON (B)(6) 2018. CONTINUOUS ANEURYSM GROWTH TO 65 MM WAS IDENTIFIED ON (B)(6) 2019. ON (B)(6) 2019, A TYPE II ENDOLEAK OF UNSPECIFIED ORIGIN WAS IDENTIFIED AND SUCCESSFULLY TREATED WITH EMBOLIZATION ON (B)(6) 2019. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 10194069 ↗
• InjurySep 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED COMPUTED TOMOGRAPHY IMAGES (DATE UNKNOWN), REVEALED THERE IS A PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM SAC ENLARGEMENT. THERE IS ALSO ENLARGEMENT OF THE LEFT COMMON ILIAC ARTERY ANEURYSM (TREATED AREA) AND A DISTAL TYPE I ENDOLEAK (PREVIOUSLY IMPLANTED PXC201400/9437286). POSSIBLE REINTERVENTION ON (B)(6) 2018.

  Patient problems: Aneurysm

  MAUDE report 7917169 ↗

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)