GORE EXCLUDER AAA Endoprosthesis with C3 Delivery RLT281218Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00733132622511), received between Aug 7, 2018 and Oct 15, 2025 — classified as 9 injuries, 3 malfunctions.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED: ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION ON IMPLANTED DISTAL LIMB (RLT281218/17597185 DEVICE) FOR PARTIALLY OCCLUSIVE THROMBUS INSIDE THE GORE® EXCLUDER® AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG. THE PHYSICIAN PERFORMED A THROMBECTOMY, THEN RELINED THE EVAR LIMB WITH A PLC141200 DEVICE (LOT #29738200). THE PATIENT ALSO HAD PARTIALLY OCCLUSIVE LESIONS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA, RLT281218/17597185 DEVICE). A THROMBECTOMY WAS PERFORMED TO ALLOW ADEQUATE BLOOD FLOW TO THE DISTAL LIMB. THE PATIENT TOLERATED THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23292366 ↗
• InjuryAug 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2018, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® EXCLUDER® AAA ENDOPROSTHESIS MAIN BODY AND TWO GORE® EXCLUDER® AAA ENDOPROSTHESES, A CONTRALATERAL LEG AND AN ILIAC EXTENDER. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, A TYPE 1 A ENDOLEAK OCCURRED ON THE MAIN BODY. THERE WAS ALSO ANEURYSM ENLARGEMENT (AMOUNT UNKNOWN) NOTED. THE PHYSICIAN USED 3 GORE® EXCLUDER® DEVICES AND 3 GORE® VIABHAN DEVICES TO RESOLVE THE REPORTED EVENT. THE PATIENT TOLERATED THE PROCEDURE. THE PHYSICIAN BELIEVES THAT THE ANEURYSM GREW, DISLODGING THE PREVIOUSLY IMPLANTED STENT. THIS LEAD TO A LACK OF CIRCUMFERENTIAL CONTACT WITH THE AORTA WHICH CAUSED THE ENDOLEAK. CAPTURED 5700-C DUE TO ANEURYSM ENLARGEMENT AMOUNT BEING UNKNOWN.

  Patient problems: Aneurysm expansion; Clinical Endoleak

  MAUDE report 19955657 ↗
• MalfunctionFeb 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS IMPLANTED WITH A 28MM X 18CM GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH C3® DELIVERY SYSTEM (EXCLUDER DEVICE) TO TREAT ABDOMINAL AORTIC ANEURYSM AND ILIAC ARTERY ANEURYSM. THE PHYSICIAN FOUND THERE WAS BLOOD INFUSION INTO CATHETER HANDLE AND 100ML BLOOD LEAKAGE. THE PHYSICIAN HURRIED DEPLOYMENT TO AVOID CONTINUOUS LEAKAGE. THE POSTOPERATIVE PATIENT HAD LOW HEMOGLOBIN AND RECEIVED A 200ML BLOOD TRANSFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18764872 ↗
• InjuryNov 2, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2023, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A PRESUMED PROXIMAL TYPE I ENDOLEAK USING A GORE® EXCLUDER®AAA ENDOPROSTHESIS AORTIC EXTENDER COMPONENT. ACCORDING TO THE PHYSICIAN, THE MAIN BODY HAD A ¿BIRD BEAK¿ ON ONE SIDE THAT MAY HAVE BEEN CAUSING THE ENDOLEAK. ADDITIONALLY, THE AORTIC NECK OF THE INFRARENAL AORTA WAS ANGLED. THE ENDOLEAK WAS RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 18059764 ↗
• InjuryApr 27, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING GORE® EXCLUDER® AAA ENDOPROSTHESES. ON (B)(6) 2022 A PROXIMAL TYPE I ENDOLEAK WAS OBSERVED ON THE TRUNK-IPSILATERAL LEG COMPONENT. IT WAS REPORTED THAT THE PATIENT IS ASYMPTOMATIC AND NO ANEURYSM ENLARGEMENT WAS REPORTED. AN INTERVENTION WILL BE SCHEDULED FOR A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14222567 ↗
• InjuryApr 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT USING 28MM X 12MM X 18CM GORE® EXCLUDER® AAA ENDOPROSTHESIS(EXCLUDER DEVICE) FOR ABDOMINAL AORTIC ANEURYSM. AFTER EXCLUDER DEVICE WAS ADVANCED THROUGH LUNDERQUIST GUIDEWIRE, THE BLOOD LEAKAGE FROM C3 HANDLE WAS OBSERVED. THE TOTAL AMOUNT OF BLOOD LOSS WAS ABOUT 800-1000ML. THE PATIENT'S HEMOGLOBIN DECREASED BY 2G AND SHOCK OCCURRED. THE PATIENT'S BLOOD PRESSURE DROPPED SIGNIFICANTLY FROM 130/90 TO 90/60. ADDITIONAL FLUIDS, BLOOD TRANSFUSION AND VASOPRESSOR THERAPY WERE PERFORMED. THERE WAS NO HURRIED DEPLOYMENT. THE PROCEDURE WAS CONTINUED WITHOUT REPORTED ISSUES PER ORIGINAL PLAN. THE PATIENT TOLERATED THE PROCEDURE AND RECOVERED WELL AFTER THE OPERATION.

  Patient problems: Shock

  MAUDE report 11683896 ↗
• MalfunctionFeb 10, 2021Break; Break

  ON (B)(6) 2021, THIS PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS TRUNK-IPSILATERAL LEG COMPONENT. AFTER DEPLOYMENT, WHEN REMOVING THE DELIVERY CATHETER, THE LEADING OLIVE BECAME SEPARATED FROM THE DELIVERY CATHETER INSIDE THE PATIENT'S BODY BUT REMAINED ON THE GUIDEWIRE. THE PHYSICIAN WAS ABLE TO RETRACT THE GUIDEWIRE AND REMOVE THE OLIVE OUTSIDE OF THE PATIENT. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11309083 ↗
• InjuryJan 5, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2020, (B)(6) WAS INFORMED THAT A PATIENT HAD A DISTAL TYPE I ENDOLEAK, AND THAT A REINTERVENTION WOULD TAKE PLACE ON (B)(6) 2020. THE PHYSICIAN STATES THAT THE ENDOLEAK IS LIKELY DUE TO DISEASE PROGRESSION RECEIVED ADDITIONAL INFORMATION FROM (B)(6). REINTERVENTION TOOK PLACE ON (B)(6) 2020. AT THAT TIME, AN EXCLUDER EXTENDER WAS IMPLANTED, WHICH STOPPED THE ENDOLEAK. PATIENT OUTCOME WAS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11117335 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2014, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, IT WAS REPORTED THAT THE PATIENT HAD AN ENDOLEAK OF INDETERMINATE ORIGIN BUT IS SUSPECTED TO BE PROXIMAL TYPE I. ANEURYSM GROWTH TO 7CM WAS REPORTED. THE PHYSICIAN PLANS TO REINTERVENE BUT NO DATE HAS BEEN SCHEDULED.

  Patient problems: Aneurysm

  MAUDE report 10445572 ↗
• MalfunctionMay 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM. THE DEVICE WAS BEING PLACED WITHIN ANOTHER EVAR GRAFT. THE FIRST STAGE OF DEPLOYMENT WAS COMPLETED. BLOOD WAS NOTED TO BE LEAKING FROM THE HANDLE. THE CONSTRAINMENT MECHANISM WAS REMOVED TO SEE IF IT WOULD HELP. THE CONTRALATERAL GATE WAS SUCCESSFULLY CANNULATED AND THE IPSILATERAL LEG WAS DEPLOYED. THE CASE WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE AND NO TRANSFUSION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8652324 ↗
• InjuryOct 10, 2018Use of Device Problem; Use of Device Problem

  ON (B)(6) 2018, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND RIGHT COMMON ILIAC ARTERY ANEURYSM WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM; AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES. IT WAS REPORTED THAT WHEN THE PREPPING THE ILIAC BRANCH COMPONENT FOR USE, THE PHYSICIAN HAD A GREAT DEAL OF DIFFICULTY WHEN REMOVING THE PROTECTIVE PACKAGING SHEATH FROM THE DEVICE. AFTER MULTIPLE ATTEMPTS, THE PHYSICAN GAVE IT A ¿HARD¿ PULL AND THE SHEATH CAME OFF. THE DEVICE WAS EXAMINED FOR ANY DAMAGE AND FOUND TO BE FIT FOR USE. THE DEVICE WAS THEN ADVANCED UP AND OVER THE BIFURCATION FOR DEPLOYMENT WHEN IT WAS NOTICED THAT WIRE ACCESS HAD BEEN LOST. THE PHYSICIAN WITHDREW THE UNDEPLOYED DEVICE FROM THE PATIENT TO REGAIN WIRE ACESS AND AT THIS TIME NOTICED THAT THE DEPLOYMENT LINE SEEMED LOOSE AND THE GRAFT SEEMED TO HAVE BEEN PUSHED FORWARD ONTO THE LEADING OLIVE. THE PHYSICAN CHOSE TO SET THIS DEVICE ASIDE AND ANOTHER ILIAC BRANCH COMPONENT WAS IMPLANTED. THE PHYSICIAN THEN ADVANCED AND DEPLOYED THE TRUNK IPSILATERAL LEG COMPONENT, BUT WAS ABLE TO CANNULATE THE CONTRALATERAL GATE. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO CANNU

  Patient problems: Aneurysm

  MAUDE report 7954043 ↗
• InjuryAug 7, 2018Use of Device Problem; Use of Device Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, THE PATIENT PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM THAT WAS INTENDED TO BE TREATED WITH GORE® EXCLUDER® ENDOPROSTHESIS. IT WAS STATED THAT THE ANEURYSM WAS NOT THROMBOSED AND THAT THE MAXIMUM DIAMETER OF THE ANEURYSM WAS 75MM. AFTER THE TRUNK-IPSILATERAL LEG COMPONENT WAS POSITIONED AND DEPLOYED WITHOUT ISSUE, IT WAS STATED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY WHEN ADVANCING THE GUIDEWIRE INTO THE CONTRALATERAL GATE OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE DEVICE WAS REPORTED TO HAVE BEEN RECONSTRAINED AND ROTATED IN ORDER TO REORIENT THE CONTRALATERAL GATE INTO A MORE OPTIMAL POSITION. THE PHYSICIAN ELECTED TO FULLY DEPLOY THE TRUNK-IPSILATERAL LEG COMPONENT AND BROUGHT A SNARE CATHETER UP AND OVER THE AORTIC BIFURCATION WITH THE INTENTION OF PULLING THE GUIDEWIRE INTO THE GATE (CODED (B)(4)). IT WAS STATED THAT AFTER THE GUIDEWIRE WAS SNARED, THE TRUNK-IPSILATERAL LEG COMPONENT LOST THE PROXIMAL SEAL AND WAS PULLED INTO THE ANEURYSM SAC. THE PHYSICIAN ELECTED TO EXPLANT THE TRUNK-IPSILATERAL LEG COMPONENT AND CONVERTED THE PATIENT TO AN OPEN SURGICAL REPAIR OF THE VASCULATURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 7755593 ↗

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)