GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT261416Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132610648), received between Dec 26, 2018 and May 11, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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.

• InjuryMay 11, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2012, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, CT IMAGING DEMONSTRATED AN ENLARGING ANEURYSM SAC MEASURING APPROXIMATELY 5.3 × 5.9 CM WITH FINDINGS SUGGESTIVE OF A TYPE II ENDOLEAK. ON (B)(6) 2026, ANGIOGRAPHIC EVALUATION WAS PERFORMED TO FURTHER ASSESS AND POTENTIALLY TREAT THE SUSPECTED TYPE II ENDOLEAK. SELECTIVE CATHETERIZATION AND EMBOLIZATION WERE ATTEMPTED; HOWEVER, DEFINITIVE CATHETERIZATION WAS NOT ACHIEVED DUE TO VESSEL TORTUOSITY. NO EMBOLIZATION WAS PERFORMED, AND THE SUSPECTED ENDOLEAK PERSISTED. ON (B)(6) 2026, CT ANGIOGRAPHY CONFIRMED A TYPE II ENDOLEAK WITHIN THE DISTAL AORTIC SAC WITH ANEURYSM SAC ENLARGEMENT MEASURING APPROXIMATELY 6.2 CM. ON (B)(6) 2026, THE PATIENT UNDERWENT AN OPEN SURGICAL REPAIR OF THE ABDOMINAL AORTIC ANEURYSM WITH EXPLANTATION OF THE AORTIC ENDOGRAFT. OPERATIVE FINDINGS INCLUDED AN EXPANDING ANEURYSM WITH A TYPE II ENDOLEAK ATTRIBUTED TO BLEEDING LUMBAR ARTERIES. A MIDLINE LAPAROTOMY WAS PERFORMED WITH EXPOSURE OF THE INFRARENAL AORTA AND BILATERAL COMMON ILIAC ARTERIES. THE ANEURYSM SAC

  Patient problems: Aneurysm expansion; Clinical Endoleak; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25137664 ↗
• InjuryFeb 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS RECEIVED BY GORE: ON (B)(6) 2014, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY IMAGING (CTA) IDENTIFIED AN ANEURYSM DIAMETER OF 61 MM. HOWEVER, A TYPE II ENDOLEAK ORIGINATING FROM THE INFERIOR MESENTERIC ARTERY AND VERTEBRAL ARTERIES WAS ALSO FOUND. IT WAS DECIDED TO MONITOR THE PATIENT. ON (B)(6) 2015, FOLLOW-UP ULTRASCAN EXAMINATION FOUND AN ANEURYSM DIAMETER OF 64 MM. BETWEEN (B)(6) 2015 AND (B)(6) 2019, THE DIAMETER WAS FOUND TO HAVE INCREASED FROM 66 TO 85 MM. ON (B)(6) 2019, AND TO TREAT THE TYPE II ENDOLEAK, A TRANSFEMORAL EMBOLIZATION OF THE INFERIOR MESENTERIC ARTERY WAS PERFORMED AND CT IMAGING SHOWED AN ANEURYSM DIAMETER OF 82 MM. LATER THAT DAY HOWEVER, THE PATIENT STARTED TO FEEL UNWELL AND WAS DIAGNOSED THE FOLLOWING DAY WITH AN ISCHEMIA OF THE LEFT AS WELL AS OF THE SIGMOID COLON. ACCORDING TO THE PHYSICIAN THE ISCHEMIA WAS BELIEVED TO BE RELATED TO THE EMBOLIZATION PROCEDURE. ON (B)(6) 2019, OSTOMY SURGERY WAS PERFORMED AND STOMA WAS CREATED TO TREATED THE COLON ISCHEMIA.

  Patient problems: No Code Available

  MAUDE report 9731941 ↗
• InjuryApr 9, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE PATIENT WAS LOST TO FOLLOW UP. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE EMERGENCY ROOM. A CT SCAN REVEALED TYPE II ENDOLEAKS ORIGINATING FROM THE L4 AND INFERIOR MESENTERIC ARTERIES. THE ANEURYSM MEASURED 85 MM. ON (B)(6) 2019, A REINTERVENTION OCCURRED WHEREBY THE L4 ARTERY AND IMA WERE COIL EMBOLIZED. AT THE END OF THE PROCEDURE, THE PATIENT SUFFERED POOLING OF BLOOD IN THE RETROPERITONEAL CAVITY. IT WAS SUSPECTED THAT THE ANEURYSM SAC RUPTURED. ON (B)(6) 2019, THE PATIENT UNDERWENT AN ADDITIONAL CT SCAN WHICH APPEARED TO SHOW A 5 MM "MARBLE" OF CALCIUM PRESENT ON THE ANTERIOR WALL APPROXIMATELY 15 MM DISTAL TO THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT. IT WAS SUSPECTED THAT THIS CALCIUM CAUSED A TYPE III (HOLE) ENDOLEAK IN THE DEVICE. THEREFORE, TWO AORTIC EXTENDER COMPONENTS WERE IMPLANTED TO TREAT THE SUSPECTED TYPE III ENDOLEAK. FINAL ANGIOGRAPHY REVEALED NO POOLING IN THE AREA OF THE SUSPECTED GRAFT HOLE. HOWEVER, ADDITIONAL TYPE II ENDOLEAKS WERE SEEN ON FINAL ANGIOGRAPHY.

  Patient problems: Aneurysm

  MAUDE report 8497763 ↗
• InjuryDec 26, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2014, THE PATIENT WAS IMPLANTED WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2018, A COMPUTED TOMOGRAPHY (CT) SCAN REPORTEDLY REVEALED A SUSPECTED PROXIMAL TYPE I ENDOLEAK CONTRIBUTING TO ANEURYSM GROWTH (AMOUNT NOT REPORTED). ON (B)(6) 2018, A FOLLOW-UP ANGIOGRAPH WAS PERFORMED. THE PHYSICIAN REPORTEDLY CONCLUDED THE ENDOLEAK WAS A TYPE II FROM TWO LUMBAR PAIRS AND A POSSIBLE SMALL ACCESSORY RENAL ARTERY. HE ELECTED TO FORGO ANY INTERVENTION, AND HAS REFERRED THE PATIENT TO INTERVENTIONAL RADIOLOGY FOR TRANSLUMBAR APPROACH EMBOLIZATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8197378 ↗

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