GORE EXCLUDER AAA Endoprosthesis PXT261416Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00733132610235), received between Jul 16, 2018 and Mar 10, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER®AAA ENDOPROSTHESIS DEVICES. ON AN UNKNOWN DATE AT POSTOPERATIVE FOLLOW-UP, A TYPE I ENDOLEAK WAS IDENTIFIED AT THE DISTAL LEFT SIDE. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED. TO ADDRESS THE DISTAL TYPE I ENDOLEAK ON THE LEFT SIDE, THE LEFT INTERNAL ILIAC ARTERY WAS EMBOLIZED, AND AN ADDITIONAL STENT GRAFT WAS EXTENDED TO THE LEFT EXTERNAL ILIAC ARTERY. ON THE RIGHT SIDE, AS A PREVENTIVE MEASURE, AN ADDITIONAL STENT GRAFTS (IBE) WERE IMPLANTED AT THE DISTAL RIGHT SIDE. THE PROCEDURE WAS COMPLETED WITH NO EVIDENCE OF ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 24555362 ↗
• InjuryJun 19, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, IT WAS REPORTED THAT FOLLOW-UP COMPUTED TOMOGRAPHY PERFORMED ON (B)(6) 2023 DETERMINED THE PATIENT WAS SYMPTOMATIC FOR ANEURYSM ENLARGEMENT AND AN UNKNOWN TYPE ENDOLEAK. THE PHYSICIAN PLANS TO RE-INTERVENE ON (B)(6) 2023. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED AT THIS TIME.

  Patient problems: Aneurysm expansion

  MAUDE report 17155850 ↗
• InjuryJun 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL ILIAC ARTERY ANEURYSMS AND WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. THE DIAMETER OF THE ANEURYSM WAS NOT KNOWN. ON (B)(6) 2017, THE PATIENT UNDERWENT FOLLOW-UP ULTRASOUND, THE MAXIMUM DIAMETER OF THE ANEURYSM WAS REPORTED TO MEASURE 75MM. ON (B)(6) 2023, THE PATIENT WAS REPORTED TO HAVE AN UNSPECIFIED ENDOLEAK WITH AN ONSET DATE OF (B)(6) 2023; IT WAS REPORTED TO BE RELATED TO THE AORTIC VESSEL DEVICE OR PROCEDURE. IT WAS ALSO REPORTED THAT DISEASE PROGRESSION IS STILL AN ISSUE FOR THE PATIENT. ON (B)(6) 2023, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY, THE MAXIMUM DIAMETER OF THE ANEURYSM WAS REPORTED TO MEASURE 106MM. ON (B)(6) 2023, THE PATIENT UNDERWENT A FOLLOW-UP A PHYSICIAN EXAMINATION, NO IMAGING WAS PERFORMED. NO OBSERVATIONS WERE PUBLISHED BY THE PHYSICIAN. ON (B)(6) 2023, THE PATIENT UNDERWENT AN AORTOGRAM WITH THE CATHETER IN THE SUPRARENAL AORTA WITHIN THE PROXIMAL STENT GRAFT AND WITHIN THE RIGHT IPSILATERAL LIMB. THE PATIENT WAS DETERMINED TO HAVE A PROXIMAL TYPE 1 ENDOLEAK FROM THE RIGHT SIDE OF THE PROXIMAL TRUNK.

  Patient problems: Aneurysm expansion

  MAUDE report 17140811 ↗
• InjuryApr 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WHICH HAD BEEN PREVIOUSLY (DATE UNKNOWN) TREATED WITH ENDOLOGIX DEVICES. GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED TO RELINE THE ENDOLOGIX DEVICES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION FOR AN ENLARGING ANEURYSM AND A TYPE III ENDOLEAK ASSOCIATED WITH A HOLE IN A DACRON GRAFT AND GORE® EXCLUDER® AAA CONTRALATERAL LIMB WAS IMPLANTED TO RELINE THE DACRON GRAFT. THE GORE ASSOCIATE SUPPORTING THIS PROCEDURE WAS MADE AWARE AT THIS TIME, THAT THE GORE DEVICES HAD BEEN EXPLANTED AND A DACRON GRAFT HAD BEEN SEWED IN ON AN UNKNOWN DATE AND YEAR BUT THOUGHT TO HAVE BEEN TEN OR SO YEARS AGO. NO ADDITIONAL INFORMATION REGARDING THE EXPLANT WAS KNOWN. THE PATIENT TOLERATED THE PROCEDURE. THE DATE OF EVENT (EXPLANT) IS ESTIMATED TO BE ON OR ABOUT (B)(6) 2013, THE REINTERVENTION ON (B)(6) 2023 IS NOT RELEVANT AS THERE WERE NO GORE DEVICES ASSOCIATED WITH THE TYPE III ENDOLEAK.

  Patient problems: Aneurysm

  MAUDE report 16736959 ↗
• InjuryMar 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 80MM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018 A CTA REVEALED THE ANEURYSM MEASURED 85MM. ON (B)(6) 2018 A TYPE II ENDOLEAK ORIGINATING FROM LUMBAR BRANCHES ORIGINATING FROM THE RIGHT INTERNAL ILIAC ARTERY WAS REPORTED. THE ANEURYSM MEASURED 102MM BY CTA. ON (B)(6) 2019 A REINTERVENTION TOOK PLACE. INITIALLY MICRO-NAVIGATION WAS ATTEMPTED TO ACCESS THE ANEURYSMAL SAC, BUT THIS WAS NOT SUCCESSFUL. THEREFORE, THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED. (THIS INFORMATION WAS CAPTURED IN THE EVENT# 40243, MEDWATCH# 2953161-2019-00033 WAS EMAILED TO FDA ON (B)(6) 2019). THE FOLLOW-UP ON (B)(6) 2019, SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS 116MM. ALSO, A TYPE II ENDOLEAK WAS DETERMINED. IT WAS REPORTED FROM THE SITE THAT IT WAS A PERSISTENT TYPE II ENDOLEAK WHICH WAS TREATED ON (B)(6) 2019. IT WAS REPORTED THAT THE TYPE II ENDOLEAK ATTRIBUTED TO THE ANEURYSM ENLARGEMENT. THE PERFUSION OF THE WALL FROM VARIOUS BRANCHES SUCH AS, LUMBAR, INTERCOSTAL AND PELVIC, INCREASED THE ANEURYSM SAC. THE ENDOLEAK ORIGIN WAS THE LUMBAR ARTERY HYPERTROPHIED WHICH CONSEQUENTLY

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

  MAUDE report 11418376 ↗
• InjurySep 23, 2020Adverse 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 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2014 A REINTERVENTION TOOK PLACE WHEREBY THE RIGHT INTERNAL ILIAC ARTERY WAS IMPLANTED WITH A COVERED SELF-EXPANDING STENT. TWO GORE® EXCLUDER® AAA ENDOPROSTHESES WERE ALSO IMPLANTED IN THIS REINTERVENTION ( PXC141400 SN (B)(4) AND PXC141200 SN (B)(4)). ON (B)(6) 2015 A PROXIMAL TYPE I ENDOLEAK WAS RECOGNIZED AND TREATED BY MEANS OF AN ADDITIONAL AORTIC ENDOGRAFT.

  Patient problems: No Code Available

  MAUDE report 10577353 ↗
• InjuryAug 10, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IN 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2015, A PROXIMAL TYPE I ENDOLEAK WAS DISCOVERED ON FOLLOW UP. THE ENDOLEAK IS ATTRIBUTED TO ANEURYSM ENLARGEMENT. ON (B)(6) 2015 A REINTERVENTION OCCURRED TO TREAT THE TYPE I ENDOLEAK. AN ADDITIONAL AORTIC ENDOGRAFT WAS IMPLANTED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10385243 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM WHICH WAS TREATED WITH TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2019 THE PHYSICIAN REPORTED THE PATIENT HAD A TYPE V ENDOLEAK. IT WAS REPORTED THAT THE ANEURYSM SAC HAD EXPANDED TO 9.8 CM. THE PHYSICIAN REPORTEDLY RELINED THE EXISTING GORE® EXCLUDER® AAA ENDOPROSTHESES. IMAGING EVALUATIONS STATE THE FINAL IMAGE APPEARS TO SHOW AN AORTIC EXTENDER AND AN ENDOLOGIC OVATION® GRAFT WITH POLYMER RINGS IMPLANTED IN ADDITION TO THE ORIGINAL EXCLUDER® DEVICE. NO FURTHER ENDOLEAKS WERE OBSERVED AND THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8723906 ↗
• InjuryApr 13, 2019Adverse 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) 2014 A PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM MEASURING 80MM WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018 A CTA REVEALED THE ANEURYSM MEASURED 85MM ON (B)(6) 2018 A TYPE II ENDOLEAK ORIGINATING FROM LUMBAR BRANCHES ORIGINATING FROM THE RIGHT INTERNAL ILIAC ARTERY WAS REPORTED. THE ANEURYSM MEASURED 102MM BY CTA. ON (B)(6) 2019 A REINTERVENTION TOOK PLACE. INITIALLY MICRO-NAVIGATION WAS ATTEMPTED TO ACCESS THE ANEURYSMAL SAC, BUT THIS WAS NOT SUCCESSFUL. THEREFORE THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED.

  Patient problems: Aneurysm

  MAUDE report 8512499 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2013, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE MAIN BODY WAS IMPLANTED ON THE WITH THE PLACEMENT OF THE IPSILATERAL LEG ON THE LEFT SIDE WITHIN THE LEFT COMMON ILIAC ARTERY. THE PROCEDURE WAS FINISHED WITH NO EVIDENCE OF ENDOLEAK OR DISSECTION REPORTED. IN (B)(6) 2018, THE PATIENT UNDERWENT FOLLOW-UP EXAMINATION WHICH REVEALED A DISSECTION OF THE LEFT EXTERNAL ILIAC ARTERY. THE CAUSE OF THE DISSECTION WAS UNKNOWN, BUT THE DISSECTION HAD NOT BEEN OBSERVED ON THE PREVIOUS FOLLOW-UP COMPUTED TOMOGRAPHY SCANS AND IT OCCURRED OUTSIDE THE TREATED REGION. THE PHYSICIAN STATED IT WAS NOT A IATROGENIC DISSECTION. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH FOR THE DISSECTION. ON (B)(6) 2019, THE PATIENT PRESENTED TO THE HOSPITAL COMPLAINING OF GLUTEAL MUSCLE CLAUDICATION. IT WAS REVEALED THAT ABI (ANKLE BRACHIAL PRESSURE INDEX) HAD DECREASED (ABI = 0.4), AND THE IPSILATERAL LEG AND THE LEFT EXTERNAL ILIAC ARTERY SHOWED STENOSIS DUE TO THROMBOSIS. THE PATIENT EMERGENTLY UNDERWENT RE-INTERVENTION FOR TREATMENT OF THE STENOSIS. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA

  Patient problems: Aneurysm

  MAUDE report 8505344 ↗
• InjuryJan 31, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH USING GORE® EXCLUDER® AAA ENDOPROSTHESES FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2019, FOLLOW-UP IMAGING REPORTEDLY IDENTIFIED A PROXIMAL TYPE I ENDOLEAK WITH NO REPORTED ANEURYSM ENLARGEMENT. IT WAS REPORTED DISEASE PROGRESSION CAUSED THE AORTIC NECK TO DILATE AND THE TRUNK-IPSILATERAL LEG COMPONENT TO LOSE APPOSITION OF THE NECK, RESULTING IN THE PROXIMAL TYPE I ENDOLEAK. ON (B)(6) 2019, AN INTERVENTION WAS PERFORMED TO TREAT THE ENDOLEAK. AN AORTIC EXTENDER COMPONENT WAS REPORTEDLY IMPLANTED FOR IMPROVED APPOSITION TO THE AORTIC WALL. REPORTEDLY, THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8293084 ↗
• InjuryJan 28, 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 ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT NON-CONTRAST SCANS (DATE IS UNKNOWN), REVEALED THE PATIENT¿S ANEURYSM SAC IS NOW 98MM (BEGINNING MEASUREMENT IS UNKNOWN). THE ENDOLEAK SOURCE IS UNKNOWN AND CANNOT BE IDENTIFIED BY SCANS DONE. THE PHYSICIAN CHOSE TO REINTERVENE ON (B)(6) 2019, AND EXTENDED PROXIMAL WITH AN AORTIC EXTENDER ENDOPROSTHESIS (PLA280300/18401586). THEN, EXTENDED DISTAL IN THE RIGHT EXTERNAL ILIAC ARTERY, HE EMBOLIZED THE HYPOGASTRIC ARTERY AND EXTENDED INTO THE RIGHT EXTERNAL ILIAC ARTERY WITH A CONTRALATERAL LEG ENDOPROSTHESIS (PLC141400/18460240). THE FINAL ANGIO RUN SHOWED A TYPE II ENDOLEAK FROM THE INTERNAL MESENTERIC ARTERY AND NO TYPE I ENDOLEAK. THE PHYSICIAN IS TAKING A WAIT AND WATCH APPROACH ON THE TYPE II ENDOLEAK. THE PATIENT TOLERATED THE REINTERVENTION PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8282775 ↗
• InjuryJul 16, 2018Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2006, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE HOSPITAL EMERGENCY DEPARTMENT WITH A RUPTURED AORTIC ANEURYSM. IMAGING REVEALED THE PROXIMAL AORTIC NECK HAD DILATED OVER TIME DUE TO DISEASE PROGRESSION. REPORTEDLY, THE TRUNK-IPSILATERAL LEG COMPONENT HAD LOSS CIRCUMFERENTIAL WALL APPOSITION AND HAD MIGRATED DISTALLY (~5CM). IT WAS REPORTED, THE ANEURYSM HAD ENLARGED (AMOUNT UNKNOWN), RESULTING IN RUPTURE. THAT SAME DAY, AN EMERGENT PROCEDURE WAS PERFORMED WHEREBY TWO MEDTRONIC AORTIC EXTENDERS WERE IMPLANTED FOR PROXIMAL EXTENSION TO THE LEVEL OF THE RENAL ARTERIES. ON (B)(6) 2018, A POST-IMPLANT ULTRASOUND IDENTIFIED EVIDENCE OF A TYPE III ENDOLEAK/DISCONNECT BETWEEN THE GORE TRUNK-IPSILATERAL LEG COMPONENT AND THE MEDTRONIC DEVICES. AN ADDITIONAL PROCEDURE WAS PERFORMED, WHEREBY AN APTUS ENDOANCHOR SYSTEM WAS USED TO FIXATE THE PREVIOUSLY IMPLANTED GORE AND MEDTRONIC DEVICES TO THE PROXIMAL AORTIC WALL. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE RUPTURE, GOOD PATENCY OF ALL DEVICES AND THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE.

  Patient problems: Atrial Perforation

  MAUDE report 7692579 ↗

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