GORE EXCLUDER AAA Endoprosthesis RLT281216Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132622504), received between Nov 30, 2018 and Jun 2, 2022 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2022Positioning Failure; Malposition of Device; Patient-Device Incompatibility; Positioning Failure; Malposition of Device; Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT HAD BEEN TREATED FOR AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ON AN UNKNOWN DATE IN 2016. THE PHYSICIAN REPORTED THAT THE CONTRALATERAL LEG WAS OCCLUDED ON (B)(6) 2022. THE CAUSE IS UNKNOWN. ON (B)(6) 2022, THE PHYSICIAN DECIDED TO RELINE THE IMPLANTED ENDOPROSTHESES WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ON AN UNKNOWN DATE. THE PATIENT DECLINED FURTHER TREATMENT AND WAS ASYMPTOMATIC.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 14575618 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD A PROXIMAL TYPE I ENDOLEAK. THERE IS NO ANEURYSM SAC ENLARGEMENT REPORTED. THE CAUSE FOR THE TYPE I ENDOLEAK IS UNKNOWN. ON (B)(6) 2020, THE PHYSICIAN REINTERVENED AND SNORKELED THE RENAL ARTIES BILATERALLY AND IMPLANTED THREE GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES PROXIMALLY TO THE SUPERIOR MESENTERIC ARTERY. THE ENDOLEAK WAS DIMINISHED BUT NOT COMPLETELY RESOLVED AT THE END OF THE CASE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 9665274 ↗
• InjuryNov 30, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, A FOLLOW-UP IMAGING REPORTEDLY IDENTIFIED AN UNKNOWN ENDOLEAK WITH NO REPORTED ANEURYSM GROWTH. ON THE SAME DAY, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT A SUSPECTED PROXIMAL TYPE I ENDOLEAK. REPORTEDLY TWO AORTIC EXTENDER COMPONENT WERE IMPLANTED FOR PROXIMAL EXTENSION ON THE TRUNK-IPSILATERAL LEG COMPONENT. FINAL ANGIOGRAPHY REPORTEDLY SHOWED A SLIGHT ENDOLEAK APPEARING TO BE A SUSPECTED TYPE II. THE PHYSICIAN IS REPORTEDLY GOING TO MONITOR THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 8120245 ↗

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