GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RMT231212Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132610501), received between Oct 16, 2018 and Oct 16, 2018 — classified as 1 injury.

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.

• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 44MM IN DIAMETER, AND WAS IMPLANTED WITH GORE® EXCLUDER® ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. FROM (B)(6) 2015 TO (B)(6) 2018 THE FOLLOW UP COMPUTED TOMOGRAPHY SCANS SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS INCREASED FROM 45MM TO 51MM. IT WAS REPORTED THAT ON (B)(6) 2018, A TYPE II ENDOLEAK FROM THE LUMBAR ARTERY WAS IDENTIFIED AND THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO EMBOLIZE THE ANEURYSM. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7971148 ↗

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)