GORE EXCLUDER AAA Endoprosthesis PXC201400Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132610051), received between Dec 21, 2018 and Mar 27, 2025 — classified as 8 injuries.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT AN UNKNOWN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, THE PATIENT WAS BROUGHT IN A FOR REINTERVENTION ON THE RIGHT SIDE WHERE THE CONTRALATERAL LEG (PXC141000) WAS IMPLANTED FOR A TYPE 1B ENDOLEAK WHICH WAS COIL EMBOLIZED THEN EXTENDED DISTALLY WITH A FLARED LIMB. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION PROCEDURE TO TREAT AN COMMON AND INTERNAL ILIAC ANEURYSM UTILIZING A GORE® DRYSEAL FLEX INTRODUCER SHEATH AS AN ACCESSORY. REPORTEDLY, THE MAIN BODY TRUNK IPSILATERAL GRAFT HAD MIGRATED DOWN BY 5CM FROM THE RENALS LEADING TO A TYPE 1B ENDOLEAK ON THE LEFT CONTRALATERAL (PXC201400) WITH ANEURYSM GROWTH IN THE COMMON ILIAC ARTERY (SIZE UNKNOWN). REINTERVENTION WAS DONE TO TREAT THE ENDOLEAK WITH IPSILATERAL IBE AND TO PRESERVE THE INTERNAL ILIAC ARTERY. DURING THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) PROCEDURE, A CONTRALATERAL SIDE UP AND OVER THE FLOW DIVIDER OF THE IBE DEVICE WAS DONE BY BASICALLY DELIVERING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) INTO THE DISTAL PART OF THE INTERNAL ILIAC ARTERY. THE D

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 21714359 ↗
• InjuryMar 19, 2025Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2025, THE PATIENT UNDERWENT RE-INTERVENTION FOR A DISTAL TYPE I ENDOLEAK FROM THE PXC201400/(B)(6) PREVIOUSLY IMPLANTED ON THE LEFT SIDE, AND ANEURYSM ENLARGEMENT TO 14CM IN DIAMETER. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND THE LEFT SIDE WAS RELINED FROM THE FLOW DIVIDER DOWN TO THE EXTERNAL ILIAC ARTERY WITH THREE CONTRALATERAL LEG COMPONENTS (PLC141400/(B)(6), PLC121400/(B)(6) AND PLC121200/(B)(6), MOST DISTAL DEVICE). THE PATIENT TOLERATED THE PROCEDURE AND THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm expansion

  MAUDE report 21646530 ↗
• InjuryApr 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SALES ASSOCIATE REPORTED THE FOLLOWING: ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2024, THE PHYSICIAN PERFORMED A REINTERVENTION PROCEDURE TO REVISE THE PREVIOUS GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE RIGHT ILIAC LIMB OF THE DEVICE HAD LOST SEAL OVER THE YEARS. THE PHYSICIAN IMPLANTED A CONTRALATERAL LEG ENDOPROSTHESIS AND EXTENDED DOWN THE RIGHT ILIAC LIMB. THERE WAS NO ANEURYSM SAC ENLARGEMENT. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE. THE ROOT CAUSE OF THE LOSS OF SEAL WAS REPORTEDLY DISEASE PROGRESSION.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 19197188 ↗
• InjuryJun 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. A TRUNK, IPSILATERAL LEG ENDOPROSTHESIS (PXT281212) WAS DEPLOYED, AND ITS IPSILATERAL LEG WAS EXTENDED BY A CONTRALATERAL LEG ENDOPROSTHESIS (PXC181000). ANOTHER CONTRALATERAL LEG ENDOPROSTHESIS (PXC201400) WAS DEPLOYED AS A CONTRALATERAL LIMB. AS THE PXC201400 LANDED ON A TIGHTLY CURVED LEFT COMMON ILIAC ARTERY, IT WAS REINFORCED BY A CORDIS PALMAZ® STENT. THE FINAL ANGIOGRAPHY CONFIRMED A TYPE ¿ ENDOLEAK, WHICH WAS DECIDED TO BE MONITORED AND LEFT UNTREATED. THE PATIENT TOLERATED THE PROCEDURE. (REF: (B)(4) ON (B)(6) 2015, REINTERVENTION WAS PERFORMED TO TREAT A PROXIMAL TYPE ENDOLEAK. WHILE SECURING THE LEFT RENAL FLOW BY USING A BOSTON SCIENTIFIC EXPRESS¿ VASCULAR SD AS A CHIMNEY GRAFT, AN AORTIC EXTENDER ENDOPROSTHESIS WAS ADDED TO THE PROXIMAL END OF THE PREVIOUSLY IMPLANTED PXT281212. THE FINAL ANGIOGRAPHY CONFIRMED NO ENDOLEAKS. THE PATIENT TOLERATED THE PROCEDURE. (REF: (B)(4). ON AN UNKNOWN DATE AROUND 2021, A FOLLOW-UP EXAMINATION CONFIRMED AN UNKNOWN AMOUNT OF ANEURYSM ENLARGEMENT. AS TREATMENT, THE PATIENT UNDERWENT AN OPEN VASCULA

  Patient problems: Aneurysm

  MAUDE report 17037619 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2013, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PATIENT IS BEING SCHEDULED FOR A LEFT ILIAC REPAIR.

  Patient problems: Aneurysm

  MAUDE report 13028303 ↗
• InjuryMar 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, AT A FOLLOW UP EXAMINATION, ANEURYSM ENLARGEMENT WAS DETECTED IN THE LEFT COMMON ILIAC ARTERY. ON (B)(6) 2021, REINTERVENTION WAS PERFORMED. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND AN ENDOPROSTHESIS WAS IMPLANTED INTO THE LEFT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THAT THE LEFT COMMON ILIAC ARTERY HAD TENDENCY OF ANEURYSM AT THE INDEX PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 11569907 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) SCAN REPORTEDLY SHOWED ANEURYSMAL DISEASE PROGRESSION INTO THE RIGHT COMMON ILIAC ARTERY. NO ENDOLEAK OR LOSS OF DISTAL APPOSITION WAS INITIALLY REPORTED. ON (B)(6) 2019, A RE-INTERVENTION PROCEDURE WAS PERFORMED WHEREBY THE RIGHT HYPOGASTRIC ARTERY WAS COIL-EMBOLIZED, AND AN ADDITIONAL EXCLUDER® COMPONENT WAS IMPLANTED TO EXTEND THE STENT GRAFT SYSTEM DISTALLY INTO THE RIGHT EXTERNAL ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8320103 ↗
• InjuryDec 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THERE WAS A REINTERVENTION ON (B)(6) 2018, TO TREAT A TYPE 1B ENDOLEAK ON THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXC201400/8472033). NO ANEURYSM SAC ENLARGEMENT WAS PRESENT BUT THERE WAS LACK OF CIRCUMFERENTIAL DEVICE APPOSITION. THE PHYSICIAN WANTED TO EXTEND THE LIMB OF THE GRAFT INTO THE EXTERNAL ILIAC ARTERY. HE EMBOLIZED THE INTERNAL ILIAC ARTERY AND THEN IMPLANTED A GORE® EXCLUDER® AAA CONTRALATERAL LEG ENDOPROSTHESIS (PLC121400/18117685). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8192403 ↗

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)