GORE EXCLUDER AAA Endoprosthesis PXC121400Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132609932), received between Mar 5, 2020 and Apr 29, 2025 — classified as 5 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 5 most recent of 5 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 21931844 ↗
• InjuryApr 17, 2025Device Endoleak; Device Endoleak

  ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DISTAL TYPE I ENDOLEAK ON A PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, AS WELL AS A REPORTED RIGHT COMMON ILIAC ARTERY ANEURYSM. THE ENDOLEAK AND ANEURYSM WERE TREATED USING ADDITIONAL GORE® EXCLUDER® AAA ENDOPROSTHESES, AND A PXC121400 CONTRALATERAL LEG COMPONENT WAS PLACED MOST DISTAL IN THE PATIENT'S RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2025, THE PATIENT PRESENTED WITH A DISTAL TYPE I ENDOLEAK ON THE PREVIOUSLY IMPLANTED CONTRALATERAL LEG COMPONENT. A REINTERVENTION WAS PERFORMED WHEREBY A PLC201400 CONTRALATERAL LEG COMPONENT AND CEB231010A ILIAC BRANCH COMPONENT WERE USED TO EXTEND THE PXC121400. IT WAS REPORTED THAT THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21858247 ↗
• InjurySep 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (RLT311413/15200324, PXC121400/15426697, PXC121000/13444897, PLC201000/13722896). THE PATIENT TOLERATED THE PROCEDURE. ON AN UNKNOWN DATE IN (B)(6) 2024, THE PATIENT WAS EVALUATED FOR TYPE II ENDOLEAK, HOWEVER, THE PATIENT DID NOT RETURN FOR ANY FOLLOW-UPS. ON AN UNKNOWN DATE IN (B)(6) 2024, THE PATIENT UNDERWENT EMBOLIZATION FOR A TYPE II ENDOLEAK. THE PROCEDURE WAS NOT SUPPORTED BY A GORE ASSOCIATE. ON (B)(6) 2024, THE PATIENT PRESENTED WITH A PROXIMAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) COUPLED WITH A RUPTURING ABDOMINAL AORTIC ANEURYSM INTO THE RETROPERITONEUM. THE PATIENT UNDERWENT SURGICAL CONVERSION AND THE TRUNK IPSILATERAL COMPONENT AND PORTIONS OF THE CONTRALATERAL LIMBS IN THE DISTAL AORTA WERE CUT OFF AND EXPLANTED. A SURGICAL GRAFT WAS THEN PLACED AND SEWED TO THE DISTAL PORTIONS OF THE GRAFTS LEFT IN PLACE. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS. THIS PROCEDURE WAS NOT SUPPORTED BY A GORE ASSOCIATE.

  Patient problems: Aneurysm expansion

  MAUDE report 20317188 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2022, A TYPE I DISTAL ENDOLEAK ASSOCIATED WITH THE LEFT ILIAC ARTERY WAS DISCOVERED ON FOLLOW UP. ON (B)(6) 2022, A REINTERVENTION OCCURRED WHEREBY EXTENSION OF THE PREVIOUSLY IMPLANTED LEFT EXTERNAL ILIAC COMPONENT WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS ILIAC BRANCH COMPONENT (B)(4) TO TREAT THE TYPE I DISTAL ENDOLEAK. THE CAUSE OF THE ENDOLEAK WAS NOT REPORTED. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2022.

  Patient problems: Aneurysm

  MAUDE report 14274430 ↗
• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THIS PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT A POSSIBLE DISTAL TYPE I B ENDOLEAK WAS PRESENT WHICH WAS CAUSING ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). REPORTEDLY THERE WAS A PAST ATTEMPT (DATE IS UNKNOWN) TO EMBOLIZE A TYPE II ENDOLEAK, THE FIELD SALES ASSOCIATE WAS NOT PRESENT AND NOT AWARE OF ANY INTERVENTION¿S UNTIL NOTIFIED DURING THE REINTERVENTION PROCEDURE ON (B)(6) 2020. ON (B)(6) 2020, THE PHYSICIAN REINTERVENED AND COILED PROXIMALLY UP INTO THE ANEURYSM SAC OF THE LEFT CONTRALATERAL SIDE OF DEVICE AND THEN IMPLANTED A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS TO EXTEND THE IMPLANTED GRAFT. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 9795494 ↗

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