GORE EXCLUDER AAA Endoprosthesis PXC121200Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00733132609925), received between Jun 15, 2020 and Jun 16, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT REINTERVENTION FOR A DISTAL TYPE I ENDOLEAK AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESES (PXC121200/(B)(6), PXL161207/(B)(6). THE PATIENT TOLERATED THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL ON (B)(6), 2014. ON (B)(6) 2015, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 66MM. ON (B)(6) 2015, THE PATIENT WAS REPORTED TO HAVE A PROXIMAL TYPE I ENDOLEAK ASSOCIATED WITH THE COOK ZENITH ENDOPROSTHESIS. ON (B)(6) 2016, FOLLOW-UP COMPUTED TOMOGRAPHY ANGIOGRAPHY DETERMINED THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM MEASURED 80.3MM. ON (B)(6) 2016, THE PATIENT UNDERWENT OPEN REPAIR WHEREIN A PARTIAL EXPLANT WAS PERFORMED. IT WAS REPORTED THAT THE COOK ZENITH DEVICE AND THE LEFT LIMB GORE® EXCLUDER® AAA ENDOPROSTHESIS WERE PRESERVED, NO ADDITIONAL DETAILS WERE PROVIDED. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE CSD REPORTS THE PATIENT DIED, THE PHYSICIAN DID NOT KNOW A CAUSE OF DEATH FOR THE PATIENT. THERE WERE NO ADVERSE EVENTS FOR THIS PATIENT AFTER 2016.

  Patient problems: Clinical Endoleak

  MAUDE report 22213883 ↗
• InjuryJun 9, 2025Insufficient Device Problem Information; Device Endoleak; Insufficient Device Problem Information; Device Endoleak

  THIS REPORT WAS SENT AS A RETRACTION. THE EVENT DESCRIPTION WAS UPDATED: ON (B)(6) 2011, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ABDOMINAL AORTIC ANEURYSM USING A COOK DEVICE. ON (B)(6) 2014, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A DISTAL TYPE I ENDOLEAK USING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES (PXC121200/13098919 AND PXL161207/12760961). THE GORE DEVICES WERE USED ON THE SAME SIDE. PRE-TREATMENT AORTIC ANEURYSM DIAMETER REMAINS UNKNOWN. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2014. THE FOLLOW UP CTA FROM (B)(6) 2015 TO (B)(6) 2016 SHOWED THAT THE MAXIMUM DIAMETER OF THE AORTIC ANEURYSM/LESION INCREASED FROM 67MM TO 80.3MM ON (B)(6) 2015, A PROXIMAL TYPE I ENDOLEAK WAS NOTED. ACCORDING TO THE PHYSICIAN THE ORIGINAL COOK DEVICE WAS ATTRIBUTED TO THE ENDOLEAK. THE PHYSICIAN BELIEVED THAT A PROGRESSIVE ANEURYSMAL DEGENERATION OF THE PARARENAL AORTA CAUSED THE ENDOLEAK, AND A PROXIMAL TYPE I ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT. REPORTEDLY, ON (B)(6) 2016 THE PATIENT UNDERWENT CONVERSION TO OPEN REPAIR. THE ENDOLEAK WAS REPAIRED WITH OPEN EXPLANT AND AORTIC RECONSTRUCTION. THE COOK ENDOGRAFT WAS MOSTLY EXPLANTED

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 22172083 ↗
• InjuryFeb 27, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE THROUGH THE GLOBAL REGISTRY FOR ENDOVASCULAR AORTIC TREATMENT (GREAT 10-11): ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM MEASURING 64.4MM IN DIAMETER, AND WAS IMPLANTED WITH GORE® EXCLUDER® ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2017, THE FOLLOW UP ULTRASOUND DETERMINED THAT THE MAXIMUM DIAMETER OF AORTIC ANEURYSM/LESION WAS 62MM. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT EXPIRED DUE TO THE ANEURYSM RUPTURE. NO TREATMENT WAS DONE. ACCORDING TO THE SITE THE EVENT WAS NOT RELATED TO THE DEVICE OR PROCEDURE. THE INFORMATION WAS PROVIDED BY RELATIVES. NO MORE INFORMATION IS AVAILABLE. THE FOLLOWING INFORMATION WAS PROVIDED FROM THE SITE: WE DON'T HAVE THE FURTHER RECORDS AS OF NOW. WE HAVE SENT THE REQUEST FOR FURTHER INFORMATION FROM (B)(6) AND ALSO (B)(6) MEDICAL CENTER WHERE HE WAS HOSPITALIZED BACK IN (B)(6) 2023. WE WILL UPDATE YOU AS SOON AS WE GET THE FORMAL DOCUMENTS. BEFORE WE GET THE FORMAL DOCUMENTS, WE CANNOT STATE IF THE EVENT WAS RELATED OR UNRELATED TO THE DEVICE. IT WILL BE UPDATED AS SOON AS WE GET THE RECORDS.

  Patient problems: Insufficient Information; Ruptured Aneurysm

  MAUDE report 18794434 ↗
• InjuryJun 12, 2023Activation, Positioning or Separation Problem; Insufficient Device Problem Information; Activation, Positioning or Separation Problem; Insufficient Device Problem Information

  ON (B)(6) 2013, THE PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES. AFTER ALL DEVICES WERE IMPLANTED, A TYPE II ENDOLEAK WAS OBSERVED. HOWEVER, NO TREATMENT FOR THE TYPE II ENDOLEAK WAS PERFORMED AND THE PROCEDURE WAS CONCLUDED. ON (B)(6) 2017, THE INFERIOR MESENTERIC ARTERY WAS LIGATED AND ANEURYSMORRHAPHY WAS PERFORMED BY THE OPEN SURGERY BECAUSE OF THE TYPE II ENDOLEAK FROM THE IMA WITH THE ANEURYSM ENLARGEMENT WAS CONFIRMED. AFTER THE REINTERVENTION ON (B)(6) 2017, IT WAS UNKNOWN IF THERE WAS ANY ENDOLEAK, BUT THE ANEURYSM WAS ENLARGED. ON (B)(6) 2023, NO ENDOLEAK WAS OBSERVED, BUT GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED PROXIMALLY OF THE TRUNK AND DISTALLY OF BOTH LEGS. AFTER ALL DEVICES WERE IMPLANTED, NO ENDOLEAK WAS OBSERVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm; Clinical Endoleak

  MAUDE report 17108738 ↗
• InjuryApr 21, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ADDITIONAL INFORMATION WAS UNAVAILABLE.

  Patient problems: Aneurysm expansion

  MAUDE report 16792522 ↗
• 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 16736948 ↗
• InjuryDec 22, 2022Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED TO GORE BY CLINICAL SPECIALIST. ON (B)(6) 2015, PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING TWO GORE EXCLUDERS RLT281414 (RIGHT) AND PXC121200 (LEFT). PRIOR TO THE IMPLANT IN 2015, PATIENT SUFFERED FROM RIGHT LOWER EXTREMITY ISCHEMIA DUE TO EMBOLIZATION FROM ABDOMINAL AORTIC ANEURYSM. PATIENT ALSO DIAGNOSED WITH LUNG CANCER THAT RADIOLOGY/ONCOLOGY REFUSED TO TREAT UNTIL ANEURYSM WAS ADDRESSED. ACCORDING TO THE PHYSICIAN, THE AORTIC ANATOMY WAS NOT IDEAL FOR ENDOVASCULAR REPAIR BUT WAS LIKELY PATIENT¿S BEST OPTION CONSIDERING COMORBIDITIES AND URGENCY TO BEGIN CANCER TREATMENT. PATIENT HAD SHORT, REVERSE TAPERED NECK WITH THE AORTIC DIAMETER AT THE RENALS WAS 18MM AND QUICKLY DILATED TO ~30MM OVER 12MM LENGTH. DURING A FOLLOW-UP SOMETIME IN (B)(6) 2022 (DATE UNKNOWN), THE PATIENT PRESENTED WITH GRAFT MIGRATION / DISEASE PROGRESSION PROXIMAL EDGE OF THE GRAFT MIGRATED DOWN (DISTALLY) AT THE LEVEL OF THE RENALS AND DID NOT COVER THE RENALS. AORTIC DIAMETER AT RENALS HAD GROWN TO 4-5CM. THE ORIGINAL GRAFT MIGRATED ~3CM. ON (B)(6) 2022, THE PATIENT WAS TREATED WITH OPEN REPAIR; GRAFT EXPLANT WAS PERFORMED. PROCEDURE WAS SUCCESSFUL WITH NO HARM TO THE PATI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040544 ↗
• InjuryMar 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. A TRUNK-IPSILATERAL LEG ENDOPROSTHESIS (RLT281216 ON THE RIGHT SIDE) AND A CONTRALATERAL LEG ENDOPROSTHESIS (PXC121200 ON THE LEFT SIDE) WERE IMPLANTED. AS REPORTED, THE PATIENT HAD YEARLY NON-CONTRAST COMPUTED TOMOGRAPHY SCANS. IN (B)(6) 2021, THE FOLLOW UP CT SHOWED A SUMMARY OF "STABLE GRAFT POSITION". THE PHYSICIAN REPORTED THAT HE DID NOT HAVE ANOTHER ENCOUNTER WITH PATIENT UNTIL LATE (B)(6) 2021, WHEN THE PATIENT COMPLAINED OF INCREASING CLAUDICATION. THE PATIENT INDICATED THAT HE HAD BEEN SEEING A PRIMARY CARE PHYSICIAN FOR THE LAST TWO YEARS, COMPLAINING OF LEG AND BACK PAIN. THE PATIENT DID HAVE SEVERAL TESTS INCLUDING X-RAY OF THE KNEE, X-RAY OF LUMBAR SPINE AND EMTS. THE PATIENT REPORTED THAT HE DID NOT SEE THE PATIENT UNTIL THE END OF (B)(6) 2021 WITH THE ABOVE-MENTIONED CLAUDICATION, AT WHICH TIME DOPPLER OF THE LOWER EXTREMITY WAS PERFORMED. THE TEST CAME BACK ABNORMAL. ON (B)(6) 2022, A CTA OF THE ABDOMEN AND PELVIS WAS PERFORMED WHICH SHOWED A THROMBOSED CONTRALATERAL LEG ENDOPROSTHESIS IN THE LEFT COMMON ILIAC. THERE WAS NO STENOSI

  Patient problems: Thrombosis/Thrombus

  MAUDE report 13667504 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2004, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2021, FOLLOW UP EXAMINATION REVEALED A TYPE 1 DISTAL ENDOLEAK FROM THE RIGHT COMMON ILIAC ARTERY. ON (B)(6) 2021 A REINTERVENTION TOOK PLACE TO TREAT THE ENDOLEAK. THE TYPE 1 DISTAL ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 12308216 ↗
• InjuryFeb 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2009, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING A GORE(R) EXCLUDER(R) AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT. THE PATIENT HAD A PERSISTENT TYPE 2 ENDOLEAK AND HAD UNDERWENT INTERVENTION WHEREBY LUMBAR ARTERIES WERE EXCLUDED VIA SURGERY AND COIL EMBOLIZATION. ON (B)(6) 2021 THE PATIENT PRESENTED WITH NO EVIDENCE OF TYPE 1 OR TYPE1B ENDOLEAKS, HOWEVER ANEURYSM ENLARGEMENT WAS NOTED. THE ANEURYSM ENLARGED TO 8CM. THE PHYSICIAN DECIDED TO EXPLANT THE GORE(R) EXCLUDER(R) AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT.

  Patient problems: Aneurysm

  MAUDE report 11267830 ↗
• InjuryAug 21, 2020Adverse 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. REPORTED THERE WAS SEEN A TENDENCY OF ENLARGEMENT OF THE RIGHT COMMON ILIAC ARTERY AND PXC121200 WAS SUCCESSFULLY IMPLANTED TO SEAL THE RIGHT COMMON ILIAC ARTERY . THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES. ON AN UNKNOWN DATE, FURTHER ENLARGEMENT OF THE THE RIGHT COMMON ILIAC ARTERY WERE NOTED. AN ENDOLEAK WAS NOT REPORTED.ON (B)(6) 2020, A REINTERVENTION TOOK PLACE WHEREBY AN ADDITIONAL STENTGRAFT WAS IMPLANTED DISTALLY.

  Patient problems: Aneurysm

  MAUDE report 10439812 ↗
• InjuryJul 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. ON (B)(6) 2020, FOLLOW UP DEMONSTRATED THAT THE RIGHT LIMB OF THE ENDOGRAFT DEMONSTRATED A SEVERE KINK WITH A SIGNIFICANT STENOSIS. ACCORDING TO THE SITE, THERE WAS PROGRESSION OF DISEASE AS THE VESSEL WAS CALCIFIED AND MILDLY ECTATIC. ON (B)(6) 2020, A RIGHT COMMON TO EXTERNAL ILIAC STENT GRAFT BALLOON EXPANDABLE COVERED STENT WAS PLACED INSIDE THE PREVIOUSLY IMPLANTED DEVICE TO TREAT THE KINK. THE KINK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10248381 ↗
• InjuryJun 15, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESIS. ON (B)(6) 2014, A TYPE II ENDOLEAK WAS DISCOVERED ON FOLLOW UP. ON (B)(6) 2014, AN AORTOGRAM WITH COIL EMBOLIZATION OF THREE SUPER SELECTED INTERNAL ILIAC ARTERY BRANCH VESSELS WERE PERFORMED. THE ENDOLEAK WAS RESOLVED.

  Patient problems: Aneurysm

  MAUDE report 10153711 ↗

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