GORE EXCLUDER AAA Endoprosthesis PXL161007Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132610068), received between Oct 18, 2019 and Apr 29, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Endoleak” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. DURING A FOLLOW-UP EXAMINATION, DISTAL MIGRATION (APPROX. 1.5 CM) OF THE TRUNK-IPSILATERAL LEG WAS NOTED. THEREFORE, A REINTERVENTION WAS INDICATED, THOUGH NO ENDOLEAK WAS SHOWN. ON (B)(6) 2025, AN ADDITIONAL PROCEDURE WAS PERFORMED. TWO AORTIC EXTENDERS WERE IMPLANTED PROXIMAL TO THE TRUNK-IPSILATERAL LEG. DURING THE PROCEDURE, IT WAS FOUND THAT THROMBUS FORMATION INSIDE THE CONTRALATERAL LEG AND ILIAC EXTENDER ON THE RIGHT SIDE. THROMBUS ASPIRATION WAS PERFORMED THROUGH THE INTRODUCER SHEATH AND AN ADDITIONAL CONTRALATERAL LEG WAS PLACED TO FIX THE REMAINING THROMBI. REPORTEDLY, THE PHYSICIAN FORGOT TO ADMINISTRATE HEPARIN BEFORE DEVICE INSERTION AND HE NOTICED IT AFTER INSERTING THE INTRODUCER SHEATH. THE PHYSICIAN THOUGHT IT WAS A CAUSE OF THROMBUS FORMATION ON THE RIGHT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21931831 ↗
• InjuryJul 2, 2024Device Endoleak; Device Endoleak

  IT WAS REPORTED THAT ON (B)(6) 2015, A PATIENT PRESENTING WITH A RIGHT COMMON ILIAC ANEURYSM WAS TREATED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS. ON (B)(6) 2018, THE PATIENT PRESENTED WITH A TYPE IIIA ENDOLEAK. ON (B)(6) 3018, AN ADDITIONAL CONTRALATERAL LEG WAS IMPLANTED TO TREAT THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 19654654 ↗
• InjuryOct 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR FOR ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. OP NOTES PROVIDED FOR CURRENT REINTERVENTION REVEALED THERE WAS A REINTERVENTION IN EARLY 2019. THE PHYSICIAN EXTENDED THE LEFT LIMB OF THE ENDOPROSTHESIS (IT IS UNKNOWN WHICH DEVICE WAS IN THE LEFT LIMB AND REINTERVENED ON) INTO THE EXTERNAL ILIAC ARTERY TO PROVIDE BETTER SEAL AND DID A TRANSCAVAL COILING WHERE FLOW CHANNEL WAS ACCESSED AND TREATED. THE PATIENT TOLERATED THIS REINTERVENTION. THERE WAS ANEURYSM SAC ENLARGEMENT WITH AN UNKNOWN CAUSE. IT WAS REPORTED THAT IMAGES (DATE AND MODALITY IS UNKNOWN) REVEALED A POSSIBLE TYPE II ENDOLEAK AND ANEURYSM SAC ENLARGEMENT. ON (B)(6) 2019, THERE WAS A REINTERVENTION. THE PHYSICIAN CHOSE TO RELINE THE GORE® EXCLUDER® AAA ENDOPROSTHESIS AND ANCHOR PROXIMALLY. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 9207763 ↗

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)