GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT261214Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132622412), received between Aug 14, 2018 and Nov 4, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Contamination” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 4, 2024Contamination; Contamination

  IT AS REPORTED TO GORE THAT A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS IMPLANTED ON (B)(6) 2015 IN ORDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE IN (B)(6) 2022, AN ENDOGRAFT INFECTION WAS DISCOVERED AND THE PATIENT RECEIVED LAPAROTOMY WITH DRAINAGE OF THE ABSCESS ON (B)(6) 2022. DUE TO THE RECURRENT ABSCESS, THE PATIENT RECEIVED ANTIBIOTIC THERAPY ON AN UNKNOWN DATE IN (B)(6) 2023. NO ANEURYSM ENLARGEMENT HAS BEEN OBSERVED DURING THE FOLLOW-UP CONTROLS.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 20598132 ↗
• InjuryAug 10, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2015, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE UTILIZING A GORE® EXCLUDER® AAA ENDOPROSTHESIS (TRUNK IPSILATERAL LEG C3 -RLT261214, CONTRALATERAL LEG -PXC141200 AND TWO AORTIC EXTENDERS -PLA280300 AND PLA260300). ON A FOLLOW UP (DATE UNKNOWN), REPORTEDLY, THE PATIENT WAS LOST TO SURVEILLANCE AND HAS A GROWING ANEURYSM (SIZE UNKNOWN) AND AN UNKNOWN ENDOLEAK, WHICH THE PHYSICIAN PRESUMES TO BE A TYPE I OR III LEAK. HOWEVER, REINTERVENTION WAS NEEDED AS THE ORIGINAL AORTIC EXTENDER IMPLANTS MAY HAVE DISCONNECTION/SEPARATION FROM THE MAIN GRAFT (TRUNK IPSILATERAL LEG C3) AND THERE IS POSSIBLY A GAP IN BETWEEN DUE TO ANEURYSM CHANGE (DISEASE PROGRESSION) AND THERE IS NO MIGRATION REPORTED. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR ZONE 9-INFRARENAL REINTERVENTION PROCEDURE TO TREAT AN ENDOLEAK UTILIZING TWO GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDERS -CXA280005). REPORTEDLY, FOR THE TREATMENT, THE PHYSICIAN PUT IN A NEW AORTIC EXTENDER TO EXTEND PROXIMALLY FROM THE FLOW DIVIDER OF THE MAIN GRAFT TO COVER THE GAP, BUT IT DID NOT RESOLVE THE LEAK, THUS, IT WAS OVERLAPPED WITH A SECOND AORTIC EXTENDER IN THE R

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 17503468 ↗
• InjuryMay 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM ON (B)(6) 2019, WITH ABDOMINAL PAIN. COMPUTED TOMOGRAPHY (CT) IMAGES REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN REINTERVENED, AND IMPLANTED TWO GORE® EXCLUDER® AAA AORTIC EXTENDER ENDOPROSTHESES. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 8656584 ↗
• InjuryAug 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED COMPUTED TOMOGRAPHY IMAGES (DATE UNKNOWN), REVEALED THERE IS A PROXIMAL TYPE I ENDOLEAK, THERE IS ANEURYSM SAC ENLARGEMENT (AMOUNT IS UNKNOWN). PATIENT PROGRESS REPORT NOTES DATED (B)(6) 2018, STATED UNDER THE PATIENTS ASSESSMENT THAT THE PATIENT WAS TREATED FOR AAA IN 2017, ANEURYSM SIZE CONTINUES TO INCREASE (AMOUNT IS UNKNOWN), TWO CT SCANS WERE PERFORMED AND THERE IS A POSSIBLE TYPE II ENDOLEAK FROM A RETROGRADE FILLING OF THE IMA IN THE SAC. ON (B)(6) 2018, THERE WAS A REINTERVENTION, THE PHYSICIAN COILED THE INTERNAL MESENTERIC ARTERY (IMA) AND THERE WAS A BALLOON ANGIOPLASTY OF THE PROXIMAL AND DISTAL PORTIONS OF THE STENTS TO REINFORCE CEILING. THE PATIENT TOLERATED THE REINTERVENTION.

  Patient problems: Aneurysm

  MAUDE report 7781638 ↗

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)