GORE EXCLUDER AAA Endoprosthesis PXC181000Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00733132610006), received between May 20, 2020 and Apr 1, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2010, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES. TWO CONTRALATERAL LEG COMPONENTS (BOTH PXC181000) WERE IMPLANTED BILATERALLY, AND A CONTRALATERAL COMPONENT (PXC201000) WAS ADDED TO EXTEND THE RIGHT LEG. THE SPECIFIC DEVICE SERIAL NUMBER IMPLANTED AT END OF THE LEFT LEG COULD NOT BE DETERMINED. ON AN UNKNOWN DATE, TYPE IB ENDOLEAKS WERE OBSERVED IN BOTH LEGS. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. REPORTEDLY, AT THE TIME OF THE REINTERVENTION, THE RIGHT INTERNAL ILIAC ARTERY WAS FOUND TO BE OCCLUDED. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED. BOTH LEGS WERE EXTENDED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES INTO THE EXTERNAL ILIAC ARTERIES. THE ENDOLEAKS WERE RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 24760690 ↗
• InjuryMar 11, 2026Patient-Device Incompatibility; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2011, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. THE FINAL ANGIOGRAPHY SHOWED A REMAINING TYPE II ENDOLEAK, BUT IT WAS LEFT FOR MONITORING. IN (B)(6) 2025, A CT SCAN SHOWED ANEURYSM ENLARGEMENT DUE TO TYPE II ENDOLEAK, AND ANEURYSMORRHAPHY WAS PLANNED. HOWEVER, IT WAS THEN FOUND THAT THE RIGHT CONTRALATERAL LEG HAD MIGRATED PROXIMALLY, LEAVING ONLY ABOUT 2 MM OF LANDING ZONE IN THE ILIAC ARTERY. THEREFORE, ADDITIONAL EVAR WAS PLANNED TO BE PERFORMED PRIOR TO THE ANEURYSMORRHAPHY. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. ANOTHER CONTRALATERAL LEG WAS PLACED DISTAL TO EXTEND THE TREATMENT AREA FOR 2 CM. THEREAFTER, ANEURYSMORRHAPHY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 24566350 ↗
• InjuryOct 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2013, THIS PATIENT UNDERWENT EMERGENCY ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM RUPTURE USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2025, A DISTAL TYPE I ENDOLEAK IN THE LEFT SIDE WAS OBSERVED. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED, ADDITIONAL STENT GRAFTS WERE PLACED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23344522 ↗
• InjuryFeb 4, 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) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. 1X TRUNK IPSILATERAL LEG AND TOTAL 4X CONTRALATERAL LEGS WERE IMPLANTED, EXTENDING TO BOTH COMMON ILIAC ARTERIES. ON AN UNKNOWN DATE, EXPANSION OF BOTH COMMON ILIAC ARTERIES WAS OBSERVED. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED. BOTH INTERNAL ILIAC ARTERIES WERE COIL-EMBOLIZED, AND ADDITIONAL STENT GRAFTS WERE PLACED IN EACH EXTERNAL ILIAC ARTERIES. FURTHERMORE, A BIRD-BEAK WAS OBSERVED AT THE PROXIMAL END OF THE TRUNK IPSILATERAL LEG. ALTHOUGH NO ENDOLEAK WAS OBSERVED, AN ADDITIONAL STENT GRAFT WAS PLACED PROXIMALLY AS A PREVENTIVE MEASURE. THE PHYSICIAN¿S COMMENT: ¿AS WE DO NOT HAVE SURGICAL RECORDS, IT IS UNCLEAR WHETHER THE INITIAL PLACEMENT OF STENT GRAFTS WAS SUBOPTIMAL OR IF THERE WAS AN ERROR IN SIZE SELECTION. ALTHOUGH MORE THAN 16 YEARS HAD PASSED SINCE THE INITIAL PLACEMENT, NO DAMAGE OR DETERIORATION OF THE DEVICE WAS OBSERVED.¿

  Patient problems: Aneurysm expansion

  MAUDE report 21303999 ↗
• InjuryFeb 12, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG AND THREE CONTRALATERAL LEGS). ON JANUARY 16 2024, THE FIELD SALES ASSOCIATE WAS NOTIFIED THAT THIS MIGHT BE A POSSIBLE REINTERVENTION NEEDED BY EXTENDING ON BOTH LIMBS FROM THE INITIAL PROCEDURE BUT NOTHING IS CERTAIN UNTIL AN ANGIOGRAM IS DONE ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION IN ZONE 9 INFRARENAL WHERE THEY DID AN ANGIOGRAM AND FOUND THERE TO BE A TYPE II ENDOLEAK FROM THE LUMBAR ARTERY, WHICH THE PHYSICIAN EMBOLIZED. THE ANEURYSM SIZE AT THE TIME OF PROCEDURE WAS 6.2CM AND PRIOR SIZE IS UNKNOWN. NO EXTENSION OR DEVICE WAS USED. THERE WAS NO TYPE 1 OR TYPE III ENDOLEAK OF ANY SORT WITH THE GRAFTS. PATIENT IS DOING WELL.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18689784 ↗
• InjuryFeb 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. AN AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED PROXIMALLY AND A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED ON THE RIGHT SIDE. ON AN UNKNOWN DATE, ENLARGEMENT OF THE ANEURYSM DUE TO A PROXIMAL TYPE I ENDOLEAK AND A RIGHT DISTAL TYPE I ENDOLEAK WAS OBSERVED. REPORTEDLY, THE TREND OF ANEURYSMAL ENLARGEMENT BECAME MORE PRONOUNCED ABOUT 3 YEARS AGO. ON (B)(6) 2024, A REINTERVENTION WAS PERFOMED. AN ADDITIONAL STENT GRAFT WAS IMPLANTED PROXIMALLY. ALSO, AN ADDITIONAL STENT GRAFT WAS IMPLANTED TO EXTEND TO THE RIGHT EXTERNAL ILIAC ARTERY AFTER EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY. ANGIOGRAPHY CONFIRMED NO ENDOLEAK AND THE PROCEDURE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18674411 ↗
• InjuryDec 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2013, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. A NON GORE DEVICE (ENDURANT STENT GRAFT SYSTEM) WAS PLACED AS THE MAIN BODY AND A CONTRALATERAL LEG ENDOPROSTHESIS WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY. ON AN UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK WAS OBSERVED FROM THE CONTRALATERAL LEG ENDOPROSTHESIS WHICH WAS PLACED ON (B)(6) 2013. ON (B)(6) 2023, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) WAS IMPLANTED TO TREAT THE DISTAL TYPE I ENDOLEAK. THE PROCEDURE WAS COMPLETED AFTER CONFIRMING THE BLOOD FLOW IN THE LEFT INTERNAL ILIAC ARTERY.

  Patient problems: Clinical Endoleak

  MAUDE report 18390815 ↗
• InjuryJul 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CLINICAL SPECIALIST (CS) REPORTED THE FOLLOWING INFORMATION: ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INFRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® ENDOPROSTHESES. IMPLANTED TWO GORE® EXCLUDER® ENDOPROSTHESES (PXC181200/(B)(6) AND PXC181000/(B)(6)) IN THE RIGHT ILIAC ARTERY. ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A RIGHT ILIAC AORTIC ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. THE REASON FOR REINTERVENTION WAS ¿RIGHT ILIAC ARTERY DEGENERATION¿. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 17372126 ↗
• InjuryJun 1, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  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. MPDCASE-00013960) 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 O

  Patient problems: Aneurysm

  MAUDE report 17037542 ↗
• InjuryMay 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A NON-GORE MANUFACTURED STENT GRAFT AS A MAIN BODY, AND A GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT IMPLANTED DISTALLY ON EACH SIDE. ON UNKNOWN DATE, A FOLLOW-UP EXAMINATION REPORTEDLY REVEALED BILATERAL DISTAL TYPE I ENDOLEAKS. ADDITIONAL EVENT INFORMATION, INCLUDING THE CAUSE OF THE ENDOLEAKS, WAS REQUESTED BUT NOT AVAILABLE. ON (B)(6) A REINTERVENTION WAS PERFORMED TO TREAT BOTH TYPE I ENDOLEAKS. THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED, AND AN ADDITIONAL GORE® EXCLUDER® COMPONENT WAS IMPLANTED TO EXTEND THE STENT GRAFT SYSTEM DISTALLY ON THE RIGHT SIDE. AN INTRA-OPERATIVE ANGIOGRAPH AT THE LEFT LEG REVEALED NO DISTAL TYPE I ENDOLEAK, BUT THE PHYSICIAN REPORTEDLY ELECTED TO IMPLANT AN ADDITIONAL GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ON THE LEFT SIDE. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 14340532 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2006, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, ANEURYSMAL DISEASE PROGRESSION INTO THE LEFT COMMON ILIAC ARTERY WAS REPORTEDLY IDENTIFIED. ACCORDING TO THE PHYSICIAN, AN ANGIOGRAM DID NOT REVEAL A SPECIFIC TYPE IB ENDOLEAK, AND NO SIGNIFICANT ANEURYSM ENLARGEMENT WAS NOTED. ON (B)(6) 2021, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE WHEREBY AN ADDITIONAL GORE® EXCLUDER® ILIAC BRANCH COMPONENT AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED TO TREAT THE LEFT COMMON ILIAC AND LEFT INTERNAL ILIAC ARTERIES. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 11753645 ↗
• InjuryDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, A DISTAL TYPE I ENDOLEAK DUE TO THE MIGRATION OF LEFT LIMB WAS OBSERVED. ON (B)(6) 2020, THE PATIENT UNDERWENT A REINTERVENTION. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS DEPLOYED TO EXTEND THE DEVICE TO THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN SUGGESTED THAT IT WAS DUE TO SLIGHTLY POOR VASCULAR CONDITION AND SHORT NECK FROM THE INITIAL PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10984295 ↗
• InjuryNov 25, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2012, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, IT WAS OBSERVED A DISTAL TYPE I ENDOLEAK AND AN ANEURYSM ENLARGEMENT. ON (B)(6) 2020, A RE-INTERVENTION WAS PERFORMED. A CONTRALATERAL LEG COMPONENT WAS PLACED TO TREAT THE DISTAL TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; No Code Available

  MAUDE report 10900460 ↗
• InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AN UNKNOWN DATE IN (B)(6) 2010, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESIS FOR AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE, A FOLLOW UP EXAMINATION REVEALED A DISTAL TYPE I ENDOLEAK. IT WAS REPORTED, A LIKELY CAUSE OF THE ENDOLEAK WAS ENLARGEMENT OF LEFT COMMON ILIAC ARTERY. ON (B)(6) 2020, THE PATIENT UNDERWENT A REINTERVENTION. THE LEFT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AND TWO ADDITIONAL STENT GRAFTS WERE DEPLOYED TO EXTEND THE DEVICE TO THE LEFT EXTERNAL ILIAC ARTERY. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10830762 ↗
• InjuryMay 20, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2011, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2016, A REINTERVENTION WAS PERFORMED TO SOLVE A TYPE 1B ENDOLEAK OF THE GORE® EXCLUDER® CONTRALATERAL LEG COMPONENT PLC181000 IMPLANTED INTO THE PATIENT¿S RIGHT COMMON ILIAC ARTERY. THE UNDERLYING CAUSE FOR THE TYPE 1B ENDOLEAK WAS REPORTED TO HAVE BEEN DISEASE PROGRESSION IN THE ABSENCE OF DEVICE MIGRATION.

  Patient problems: Aneurysm

  MAUDE report 10073990 ↗

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)