GORE EXCLUDER AAA Endoprosthesis PLC161400Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132618729), received between Apr 8, 2021 and Apr 24, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2024, THIS PATIENT UNDERWENT PLANNED ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS DEVICES. ON (B)(6) 2026, THE PATIENT PRESENTED WITH A RIGHT-SIDE COLD LEG. IT WAS DETERMINED THAT THERE WAS THROMBUS PRESENT IN THE GORE® EXCLUDER® ILIAC EXTENDER PREVIOUSLY IMPLANTED ON THE RIGHT SIDE AND THAT THE RIGHT INTERNAL ILIAC ARTERY WAS OCCLUDED. THE PATIENT UNDERWENT REINTERVENTION. AN EMBOLECTOMY WAS PERFORMED ON THE RIGHT SIDE AND THE LIMB WAS EXTENDED WITH AN ADDITIONAL GORE® EXCLUDER® ILIAC EXTENDER. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24990568 ↗
• InjuryMar 30, 2026Collapse

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (TRUNK-IPSILATERAL LEG), WITH DEPLOYMENT OF A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT ON THE CONTRALATERAL SIDE. ON (B)(6) 2026, REINTERVENTION WAS REQUIRED DUE TO COMPRESSION OF THE LEFT CONTRALATERAL LIMB AT THE LEVEL OF THE FLOW DIVIDER OF THE PREVIOUSLY IMPLANTED GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. THE COMPRESSION INVOLVED THE PRIMARY (PROXIMAL), GATE-SEATED CONTRALATERAL LEG, WITH NO COMPRESSION OF THE TRUNK COMPONENT. THE COMPRESSION WAS ATTRIBUTED TO PATIENT-SPECIFIC ANATOMY/PATHOLOGY IMMEDIATELY DISTAL TO THE FLOW DIVIDER, RATHER THAN A DEVICE-RELATED MECHANICAL ISSUE SUCH AS GRAFT INFOLDING OR KINKING. LIMB COMPRESSION WAS INITIALLY DETECTED ON CT IMAGING, WHICH DEMONSTRATED A SLIGHT NARROWING OF THE AFFECTED SEGMENT. ALTHOUGH CLINICAL SYMPTOMS WERE NOT REPORTED PRIOR TO REINTERVENTION, THE PHYSICIAN ELECTED TO PERFORM ANGIOGRAPHY TO FURTHER ASSESS THE FOCAL AREA AND DETERMINE THE APPROPRIATE TREATMENT MODALITY. DURING THE REINTERVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713146 ↗
• InjurySep 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN UNKNOWN APPLICATION UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 AND CONTRALATERAL LEG). ON (B)(6) 2025, FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT THERE IS A TYPE 1A AND 1B ENDOLEAK ON THE PATIENT'S RIGHT SIDE WITH AN EXCLUDER GRAFT. ON (B)(6) 2025, ADDITIONAL INFORMATION RECEIVED THAT THERE IS A CONFIRMED TYPE 1A ENDOLEAK BASED ON CT SCANS AS ANEURYSM HAS GROWN TO 7CM. PHYSICIAN IS PLANNING A REINTERVENTION BUT PROCEDURAL DETAILS AND DATE HAS NOT BEEN DECIDED YET.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 23015590 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 54MM IN DIAMETER AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 54MM. ON (B)(6) 2025, THE PATIENT WAS CONVERTED TO OPEN REPAIR DUE TO RAPID EXPANSION OF THE ANEURYSM TO 87MM AND THE DEVICES WERE EXPLANTED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion

  MAUDE report 22869335 ↗
• InjuryJun 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PRIOR ENDOVASCULAR REPAIR WITH A MEDTRONIC AFIX GRAFT AND A VELA CUFF. GORE® EXCLUDER®AAA ENDOPROSTHESIS WERE IMPLANTED TO TREAT A PROXIMAL TYPE I ENDOLEAK DUE TO SUSPECTED MIGRATION OF THE MEDTRONIC DEVICES. PRE-TREATMENT MAXIMUM AORTIC DIAMETER MEASURED 52MM. ON (B)(6) 2024, THE SITE REPORTED THE PATIENT HAD A TYPE III ENDOLEAK. ON (B)(6) 2024, THE PATIENT UNDERWENT OTHER TREATMENT OR PROCEDURE FOR THE TYPE III ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL DETAILS HAVE BEEN REQUESTED.

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

  MAUDE report 19525229 ↗
• InjuryFeb 6, 2024Device Stenosis; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM AND UNDERWENT TREATMENT UTILIZING THREE GORE® EXCLUDER® AAA ENDOPROSTHESES (ONE RLT DEVICE & TWO PLC DEVICES). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT PRESENTED WITH INVAGINATION OF THE PREVIOUSLY PLACED RLT DEVICE IN THE INFRARENAL AORTA AND UNDERWENT TREATMENT UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (PLA). THE PLA DEVICE WAS IMPLANTED SUCCESSFULLY, AND THE INVAGINATION WAS RESOLVED BY COVERAGE FROM THE PLA DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2022, THE PATIENT REPORTED TO GORE THAT THEIR KIDNEYS HAD BEEN OCCLUDED. ADDITIONAL INFORMATION WAS REQUESTED FROM THE PHYSICIAN BUT WAS NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ABOUT THE REINTERVENTION EVENT FROM MEDICAL RECORDS ON JANUARY 11, 2024: ON (B)(6) 2022, DURING THE REINTERVENTION PROCEDURE, ANGIOGRAM WAS DONE THAT SHOWED THE TRUNK IPSILATERAL GRAFT HAD FOLDED ON ITSELF IN THE INFRARENAL AORTA AND RESULTED IN A NEAR OCCLUSION AND THERE WAS SEVERE STENOSIS IN THE LEFT LIMB (GORE® EXCLUDER® AAA ENDOPROSTHESIS, CONTRALATERAL LEG, PLC16L400). TO RESOLVE THE INFOLDING, A

  Patient problems: Pelvic Pain; Stenosis

  MAUDE report 18655737 ↗
• InjuryJan 3, 2024Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. PRE-TREATMENT CTA SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 60.8MM. FROM (B)(6) 2014 TO (B)(6) 2020 THE FOLLOW UP SCANS SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 55MM TO 107MM. ADDITIONALLY, ON (B)(6) 2020, A DISTAL RIGHT LIMB TYPE I ENDOLEAK WAS DETERMINED. IT WAS REPORTED THAT A LOSS OF SEAL OF THE RIGHT DISTAL ILIAC LIMB TO THE COMMON ILIAC ARTERY CAUSED A DISTAL TYPE I ENDOLEAK. THE PATIENT HAD A SEVERE TORTUOSITY OF THE RIGHT ILIAC SYSTEM. REPORTEDLY, A DISTAL TYPE I ENDOLEAK CAUSED AN ANEURYSM ENLARGEMENT. ON (B)(6) 2021, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING GORE EXCLUDER AAA ENDOPROSTHESES (PLC201400/ 2258291 AND PLC181400/ 22477819). THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18441447 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. PRE-TREATMENT CTA SHOWED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 60.8MM. THE PATIENT HAD THE MULTIPLE REINTERVENTIONS FROM PROGRESSING TYPE I AND TYPE II ENDOLEAKS WHICH HAVE BEEN ALREADY INVESTIGATED AND REPORTED TO FDA. REPORTEDLY, ENDOLEAKS WERE FIXED AND THE PATIENT TOLERATED THE PROCEDURE. ON SEPTEMBER 19, 2022, A TYPE III ENDOLEAK-COMPONENT DISCONNECTION WAS DISCOVERED. THE AORTIC ANEURYSM WAS 114MM. ACCORDING TO THE SITE, THE ANEURYSM ENLARGEMENT WAS DUE TO THE TYPE III ENDOLEAK. THE MULTIPLE PREVIOUS REINTERVENTIONS FROM PROGRESSING ENDOLEAKS CAUSED A TYPE III ENDOLEAK. ON (B)(6), 2022, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A TYPE III ENDOLEAK USING A PLC181000/ 22553344 DEVICE. ACCORDING TO THE SITE, THE EVENT WAS RELATED TO THE DEVICE OR PROCEDURE. THE ENDOLEAK WAS FIXED. THE PATIENT TOLERATED THE PROCEDURE. FOLLOW UP EXAMINATION ON AUGUST 25, 2014 SHOWED THE ANEURYSM MEASURED 55 MM. FROM DECEMBER 13, 2022 TO FEBRUARY 16, 2023 THE FOLLOW UP SCANS SHOWED THAT THE MAXIMUM DIAME

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 18288481 ↗
• MalfunctionAug 9, 2023Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Separation Problem; Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Separation Problem

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. REPORTEDLY, AFTER THE GORE® DRYSEAL SHEATH INSERTION, THE END PART OF THE CATHETER BROKE OFF AND HAD TO BE SNARED OUT. ACCORDING TO THE PHYSICIAN, IT IS UNKNOWN WHAT CAUSED THE PROBLEM. THERE WAS NOTHING STRANGE ABOUT THE PATIENT¿S ANATOMY AND THERE WAS NO RESISTANCE FELT OR ANY DIFFICULTY MOVING THE DEVICE. THE DAMAGE WAS NOTED AT THE TIP OF THE DEVICE AFTER THE DEPLOYMENT SYSTEM HAD BEEN REMOVED. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 17495385 ↗
• InjuryApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2022, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A RUPTURED LEFT COMMON ILIAC ARTERY ANEURYSM (LCIAA) AND A SMALL ABDOMINAL AORTIC ANEURYSM (AAA) AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS AND NO ENDOLEAK VISUALIZED. ON (B)(6) 2022, THE PATIENT UNDERWENT FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY AND A DISTAL TYPE I ENDOLEAK WAS VISUALIZED. THE PATIENT UNDERWENT REINTERVENTION AND AN ADDITIONAL CONTRALATERAL LEG COMPONENT WAS PLACED TO EXTEND COVERAGE AND RESOLVED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE, NO ANEURYSM ENLARGEMENT WAS REPORTED.

  Patient problems: Ruptured Aneurysm

  MAUDE report 14242605 ↗
• MalfunctionApr 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6), 2009, THE PATIENT WAS TREATED FOR AN AORTIC ABDOMINAL ANEURYSM. SIX EXCLUDER DEVICES WERE IMPLANTED, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2021, THE PATIENT WAS TREATED EMERGENTLY FOR A RUPTURED ANEURYSM. IT WAS DETERMINED THAT A TYPE III ENDOLEAK HAD OCCURRED BETWEEN TWO COMPONENTS, ALLOWING THE ANEURYSM TO EXPAND AND RUPTURE. A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS PLACE IN THE GAP BETWEEN THE TWO SEPARATED DEVICES. AFTER SUCCESSFULLY PLACING THE DEVICE, AS THE DELIVERY CATHETER WAS BEING REMOVED, THE OLIVE TIP SEPARATED FROM THE CATHETER. THE PHYSICIAN WAS ABLE TO RETRIEVE THE OLIVE, AND THE PATIENT TOLERATED THE PROCEDURE. THE DELIVERY CATHETER WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11638161 ↗

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)