GORE EXCLUDER AAA Endoprosthesis PXL161207Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132610075), received between Mar 10, 2021 and Feb 10, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2010, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A DISSECTING ANEURYSM IN THE LEFT ILIAC ARTERY USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (ILIAC EXTENDER ENDOPROSTHESIS). ON AN UNKNOWN DATE, ANEURYSM ENLARGEMENT WAS OBSERVED (DETAILS UNKNOWN). ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND THEN A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED TO EXTEND THE INITIAL ILIAC EXTENDER ENDOPROSTHESIS INTO THE LEFT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 24301871 ↗
• InjuryDec 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON AN UNSPECIFIED DATE IN 2002 THE PATIENT WAS IMPLANTED WITH A NON-GORE AORTIC TRUNK DEVICE (ANCURE) FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011 THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER (PXL161407). ON (B)(6) 2013 A REINTERVENTION OCCURRED IN WHICH THE EXISTING CONFIGURATION, INCLUDING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC EXTENDER, WAS RELINED WITH THE FOLLOWING GORE DEVICES: 3 GORE® EXCLUDER AORTIC EXTENDER ENDOPROSTHESIS (PXA230300), 1 GORE® EXCLUDER CONTRALATERAL LEG ENDOPROSTHESIS (PXC121000), AND 1 GORE® ILIAC EXTENDER ENDOPROSTHESIS (PXL161207). THE SPECIFIC REASON FOR THE REINTERVENTION IS UNKNOWN. ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A TYPE IB ENDOLEAK. IT IS UNKNOWN WHEN THE ENDOLEAK WAS FIRST IDENTIFIED. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. AS REPORTED THERE WAS OBSERVED DILATION ON THE LEFT COMMON ILIAC. COIL EMBOLIZATION OF THE LEFT INTERNAL ILIAC WAS PERFORMED AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT (PLC121400) WAS LANDED IN THE LEFT EXTERNAL ILIAC IN ORDER TO ADDRESS THE ENDOLEAK AND EXTEND COVERAGE. A LACK OF CIRCUMFERENTIAL SEAL WAS NOTED IN

  Patient problems: Aneurysm

  MAUDE report 13048892 ↗
• InjuryDec 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK WAS REPORTEDLY OBSERVED ON THE PATIENT'S RIGHT SIDE. AN ADDITIONAL STENT GRAFT WAS PLACED TO TREAT THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED IN RELATION TO THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12960661 ↗
• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015. THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. ON (B)(6) 2018. A RUPTURE OF THE RIGHT INTERNAL ILIAC ARTERY ANEURYSM WAS REPORTED. THE PATIENT WAS CONVERTED TO OPEN REPAIR TO TREAT THE RUPTURE.

  Patient problems: Ruptured Aneurysm

  MAUDE report 11454877 ↗

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)