GORE EXCLUDER AAA Endoprosthesis PXT281418Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132610327), received between Sep 3, 2020 and Jan 6, 2026 — classified as 1 death, 8 injuries.

The most frequently reported specific device problem is “Device Endoleak” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Material Puncture/Hole; Device Endoleak

  ON (B)(6) 2006, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM (AAA) UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PXT281418). REPORTEDLY, ON (B)(6) 2025, THE PATIENT HAD AN ULTRASOUND WHICH REVEALED A HOLE IN THE IPSILATERAL LIMB OF THE PXT281418. THE PHYSICIAN PERFORMED AN ANGIOGRAM WHICH CONFIRMED THE HOLE AND AN ASSOCIATED TYPE 3 ENDOLEAK DUE TO THE HOLE. IT IS UNKNOWN IF THERE WAS ANEURYSM ENLARGEMENT ASSOCIATED WITH THE ENDOLEAK. THE CAUSE OF THE HOLE IN THE DEVICE IS UNKNOWN. IT WAS REPORTED THE PATIENT HAD NO CLINICAL SEQUELAE ASSOCIATED WITH THE ENDOLEAK. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO RELINE THE IPSILATERAL LIMB IN THE LEFT ILIAC UTILIZING TWO GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEGS (PLC141400 AND PLC161000). THERE ARE NO CLINICAL IMAGES AVAILABLE. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23980703 ↗
• InjuryJan 6, 2026Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2009, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK-IPSILATERAL LEG) AND A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT). ON (B)(6) 2025, THE PATIENT REQUIRED ENDOVASCULAR REINTERVENTION TO ADDRESS BOTH A TYPE 1A AND TYPE 1B ENDOLEAK CONTRIBUTING TO ANEURYSM ENLARGEMENT, WITH THE ANEURYSM SAC MEASURING 10CM AT THE TIME OF REINTERVENTION. THE PROCEDURE INCLUDED EMBOLIZATION OF THE LEFT INTERNAL ILIAC ARTERY, THEN DISTAL EXTENSION OF THE LEFT LIMB WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS (CONTRALATERAL LEG COMPONENT) INTO THE LEFT EXTERNAL ILIAC ARTERY IN ORDER TO TREAT THE TYPE 1B ENDOLEAK, AND PLACEMENT OF ENDO ANCHORS AT THE PROXIMAL END OF THE TRUNK TO RESOLVE THE TYPE 1A ENDOLEAK. IT WAS REPORTED THAT THE ENDOLEAKS WERE ATTRIBUTED TO DEGENERATION OF THE ARTERIES DISTAL TO THE PREVIOUSLY IMPLANTED GRAFTS. THE PATIENT TOLERATED THE PROCEDURE WITHOUT COMPLICATIONS.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23974551 ↗
• InjuryNov 21, 2023Patient-Device Incompatibility; Device Endoleak; Patient-Device Incompatibility; Device Endoleak

  ON (B)(6) 2009, THIS PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2022, FOLLOW-UP COMPUTED TOMOGRAPHY IMAGING IDENTIFIED A TYPE 1A ENDOLEAK. AN ENLARGEMENT OF THE ANEURYSM WAS NOT REPORTED. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED AND THE ENDOLEAK WAS SUCCESSFULLY SOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18181638 ↗
• InjuryFeb 2, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2010, THIS PATIENT UNDERWENT AN EMERGENCY ENDOVASCULAR TREATMENT FOR THE RUPTURED ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. REPORTEDLY, THE ANEURYSM SIZE WAS ABOUT 9 CM. ON AN UNKNOWN DATE, POSTOPERATIVE FOLLOW-UP, A TENDENCY OF MIGRATION OF THE LEFT LEG/IPSILATERAL LEG WAS CONFIRMED. THE AMOUNT OF THE MIGRATION WAS UNKNOWN. ON (B)(6) 2021, FOLLOW-UP CT SCAN SHOWED MIGRATION OF THE LEFT LEG INTO THE ANEURYSM SAC, RESULTING IN A DISTAL TYPE I ENDOLEAK. ON (B)(6) 2022, A REINTERVENTION WAS PERFORMED. AN ADDITIONAL STENT GRAFT WAS IMPLANTED INTO THE LEFT DISTAL SIDE. IT WAS REPORTED THAT THE ENDOLEAK WAS FIXED. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE SIZE OF THE DISTAL LEFT LEG AT THE INDEX PROCEDURE MAY HAVE BEEN UNDERSIZED, HOWEVER, THE TREATMENT LENGTH FOR THE INDEX PROCEDURE WAS UNKNOWN. ADDITIONALLY, NO COMMENT WAS RECEIVED FROM THE PHYSICIAN REGARDING THE CAUSE OF MIGRATION.

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

  MAUDE report 13431172 ↗
• InjuryDec 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2007, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES (MAIN TRUNK AND PXC141200/(B)(4), PXC181400/(B)(4), PXL161407/(B)(4)). THE REASON FOR TREATMENT WAS NOT PROVIDED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, IT WAS REPORTED, THAT THE PATIENT UNDERWENT EXPLANT OF THE GORE® EXCLUDER® AAA TRUNK IPSILATERAL LEG COMPONENT. THE REASON FOR THE EXPLANT IS UNKNOWN. A GORE ASSOCIATE WAS NOTIFIED BY THE PHYSICIAN'S STAFF OF THE EXPLANT AND WAS NOT PRESENT TO SUPPORT THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND WAS REPORTED TO BE DOING FINE. NO FURTHER INFORMATION WAS PROVIDED; THE INVESTIGATION IS ONGOING. ANY ADDITIONAL INFORMATION OBTAINED WILL BE PROVIDED BY SUBMISSION OF A SUPPLEMENTAL MEDWATCH.

  Patient problems: Aneurysm

  MAUDE report 13058990 ↗
• InjuryOct 21, 2021No Apparent Adverse Event; No Apparent Adverse Event

  ON (B)(6) 2008, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2017, THE PATIENT UNDERWENT REINTERVENTION AND CONTRALATERAL LEG COMPONENT WAS IMPLANTED. NO FURTHER INFORMATION IS KNOWN AT THIS TIME.

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

  MAUDE report 12676918 ↗
• DeathJan 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2012, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 87MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE TRUNK IPSILATERAL LEG COMPONENT WAS SUCCESSFULLY DEPLOYED WITH THE CONTRALATERAL GATE ON THE RIGHT SIDE AND EXTENDED WITH PLACEMENT OF A CONTRALATERAL LEG COMPONENT. CONTROL ANGIOGRAPHY DETERMINED A DISTAL TYPE I ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY (RCIA) AND ADDITIONAL ANGIOPLASTY WAS PERFORMED WITH A CODA BALLOON CATHETER TO RESOLVE THE ENDOLEAK. IT WAS REPORTED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION WAS DECREASED IN SIZE FROM 82MM FROM (B)(6) 2012 TILL 63MM ON CT DATED (B)(6) 2018. NO MORE CT IMAGES WERE PROVIDED LATER DUE TO THE PANDEMIC SITUATION. REPORTEDLY, ON (B)(6) 2021, THE PATIENT WAS ADMITTED AT A (B)(6) HOSPITAL IN (B)(6) WITH AN ABDOMINAL PAIN, VOMIT AND EVACUATING. A CT SCAN WAS PERFORMED AND DETECTED AN ANEURYSM BLEEDING. ACCORDING TO THE INFORMATION PROVIDED FROM THE SITE, THE PROBABLE ANEURYSM RUPTURE WAS DETERMINED. ON (B)(6) 2021, THE PATIENT EXPIRED. ACCORDING TO THE SITE, THE EVENT RELATED TO THE AORTIC DEVICE OR PROCEDURE. ADDITIONAL INFORMATION WAS REQUE

  Patient problems: Aneurysm; Death

  MAUDE report 11167631 ↗
• InjuryNov 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2010, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON AN UNKNOWN DATE, IMAGES SHOWED 1 CM OF ANEURYSM GROWTH FROM 5.5 CM TO 6.5 CM. ALTHOUGH IMAGES SHOWED THE MOST PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS APPROXIMATELY 1 CM BELOW THE MOST DISTAL RENAL, THERE WAS NO EVIDENCE OF A TYPE I ENDOLEAK. ON (B)(6) 2020, A REINTERVENTION WAS PERFORMED WHEREBY 2 GORE® EXCLUDER® AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENTS WERE IMPLANTED TO EXTEND PROXIMALLY TO THE MOST DISTAL RENAL ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 10826015 ↗
• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2006, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED TWO GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE PATIENT REPORTED EMERGENTLY WITH A TYPE IA ENDOLEAK AND RUPTURE. THE PATIENT WAS TREATED WITH A NON-GORE DEVICE.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 10489192 ↗

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)