GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT281218Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132610693), received between Feb 25, 2019 and Feb 25, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS TREATED WITH THE IMPLANTATION OF GORE® EXCLUDER® AAA ENDOPROSTHESES. THE POST-OPERATIVE ANEURYSM DIAMETER WAS REPORTED TO BE 33 MM. ON (B)(6) 2018, A PROXIMAL TYPE I ENDOLEAK WAS IDENTIFIED ALONG WITH A 60 MM ANEURYSM DIAMETER. THE CAUSE OF THE ENDOLEAK COULD BE DISEASE PROGRESSION, BUT WAS NOT CONFIRMED. THE ENDOLEAK WAS SUCCESSFULLY SOLVED WITH THE IMPLANTATION OF A GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESIS ON (B)(6) 2019.

  Patient problems: No Code Available

  MAUDE report 8365372 ↗

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)