GORE PROPATEN Vascular GraftRecalls & reported problems across all models

We found 11 models of GORE PROPATEN Vascular Graft by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2018 and Nov 25, 2025 — classified as 5 deaths, 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE PROPATEN Vascular Graft problems

GORE PROPATEN Vascular Graft models

11 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE PROPATEN Vascular Graft HT066080A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  4 reports
• GORE PROPATEN Vascular Graft HT087080A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 deaths4 reports
• GORE PROPATEN Vascular Graft H060040A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• GORE PROPATEN Vascular Graft H470045A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 death2 reports
• GORE PROPATEN Vascular Graft HAX02A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• GORE PROPATEN Vascular Graft H080040A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 death1 report
• GORE PROPATEN Vascular Graft HT064050A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE PROPATEN Vascular Graft HT066070A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE PROPATEN Vascular Graft HT067090A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE PROPATEN Vascular Graft HT083040A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 death1 report
• GORE PROPATEN Vascular Graft HAX01A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report

Recent GORE PROPATEN Vascular Graft adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS TREATED FOR AN URGENT ACUTE LIMB ISCHEMIA (ALI). THE PHYSICIAN PERFORMED A FEMORAL-TIBIAL BYPASS (ATA) PROCEDURE IN THE LOWER LEFT LEG. THE PATIENT WAS IMPLANTED WITH A GORE® PROPATEN® VASCULAR GRAFT (VASCULAR GRAFT). ENDARTERECTOMY WAS ALSO PERFORMED. AS REPORTED, THERE WAS NOTHING UNUSUAL ABOUT PROCEDURE, BUT SEROMA WAS NOTICED SOMETIME AFTER THE ATA PROCEDURE. THE PATIENT HAS HAD SEROMA FOR ABOUT A YEAR. THE VASCULAR GRAFT IS STILL PATENT, AND PULSE IS PRESENT ON DOPPLER. IT WAS REPORTED THE PATIENT HAS NO VEIN FOR AN AUTOLOGOUS BYPASS. ON (B)(6) THE PHYSICIAN REVISED THE VASCULAR GRAFT. THE FLUID WAS DRAINED AND ABOUT 500ML OF CLEAR FLUID, WHICH WAS SUBMITTED FOR MICROBIAL TESTING (NO RESULTS PROVIDED). THE CAPSULE AROUND THE FLUID WAS EXCISED. TISSUE INCORPORATION WAS OBSERVED AROUND THE VASCULAR GRAFT NEAR THE ANASTOMOSES, BUT LESS SO IN THE CENTER OF THE GRAFT. THE VASCULAR GRAFT WAS WRAPPED TIGHTLY WITH A 7MM ARTEGRAFT (TIGHT SLEEVE AROUND THE PTFE GRAFT WITH VISIBLE RINGS) AND ABOUT 40CM GRAFT LENGTH WAS COVERED. THE VASCULAR GRAFT WAS THEN RE-TUNNELED AND SEWN BACK TOGETHER. IT WAS REPORTED THE PHYSICIAN DI

  Patient problems: Seroma

  MAUDE report 23646987 ↗
• MalfunctionMay 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025 A GORE® PROPATEN® VASCULAR GRAFT IMPLANTED IN AN UNKNOWN ANATOMICAL LOCATION DURING TREATMENT OF AN UNKNOWN ETIOLOGY. AFTER THE GRAFT WAS SEWED IN. THE PHYSICIAN PERCUTANEOUSLY INSERTED AN 18-GAUGE NEEDLE AND J-WIRE INTO THE GRAFT. HE THEN PROCEEDED TO INSERT A 5FR CORDIS SHORT SHEATH AND THE GRAFT TORE. HE WAS ABLE TO SEW THE GRAFT TO CLOSE THE HOLE. PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010007 ↗
• InjuryJan 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, A PATIENT REPORTEDLY UNDERWENT TREATMENT FOR PERIPHERAL ARTERIAL DISEASE (OCCLUDED DISTAL AORTA AND BILATERAL COMMON ILIAC ARTERIES) WITH DEBILITATING SHORT DISTANCE CLAUDICATION AND RIGHT LEG WOUNDS, WHERE A GORE® PROPATEN® VASCULAR GRAFT WAS USED IN AN AXILLO-BIFEMORAL BYPASS WITH BILATERAL FEMORAL ENDARTERECTOMY PROCEDURE. IT WAS ALLEGED THERE WAS NO INFECTION PRESENT AT THE TIME OF THE SURGERY. ON (B)(6), 2023 (53 DAYS POST INITIAL SURGERY), THE PATIENT REPORTEDLY PRESENTED AT THE HOSPITAL WITH PAIN IN LOWER BACK, FEVER, AND SOME DISCHARGE FROM RIGHT GROIN INCISION. ON (B)(6) 2023, THE PATIENT UNDERWENT EMERGENCY EXPLORATORY SURGERY. IT WAS REPORTED, DURING THE PROCEDURE, AN UNINCORPORATED PORTION OF THE GRAFT THAT APPEARED TO BE INFECTED (SIGNS OF PURULENCE AND DISRUPTED SUTURE LINE) WAS EXPLANTED. THE REMAINING GRAFT ON THE RIGHT SIDE AND THE ENTIRE GRAFT ON THE LEFT SIDE OF THE PATIENT WERE NOT EXPLANTED. ON (B)(6) 2024 THE PATIENT WAS REPORTEDLY DISCHARGED AND TRANSFERRED TO ANOTHER FACILITY. ON (B)(6) 2024. THE PATIENT WAS ALLEGEDLY READMITTED TO THE FIRST HOSPITAL AND BLOODWORK CONFIRMED THE PRESENCE OF STAPHYLOCOCCUS AUREUS IN SYSTEM, INDICATING ON-GOING

  Patient problems: Bacterial Infection

  MAUDE report 21242741 ↗
• InjuryFeb 1, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2023, A PATIENT UNDERWENT FEMORAL POPLITEAL BYPASS SURGERY FOR PERIPHERAL ARTERIAL DISEASE (PAD) AND CLAUDICATION USING A GORE® PROPATEN® VASCULAR GRAFT IN THE RIGHT LEG. ON (B)(6) 2023, THE PATIENT UNDERWENT THROMBECTOMY FOR A THROMBOSED GRAFT. SOME SEROMA FLUID WAS NOTED AND CULTURED AT THIS TIME. THE CULTURE WAS NEGATIVE. ON AN UNKNOWN DATE, THE PATIENT RETURNED WITH A RED SKIN RASH WHERE THE GRAFT WAS IMPLANTED. IT WAS TREATED WITH TOPICAL ANTIBIOTICS AND CIPROFLOXACIN, WHICH CLEARED IT UP. ON (B)(6) 2024 THE GRAFT WAS EXPLANTED. REPORTEDLY, THE GRAFT WAS PATENT, BUT THERE WAS A LARGE SEROMA FROM THE FEMORAL TO POPLITEAL, AND THE PATIENT WAS SYMPTOMATIC. THE ENTIRE GRAFT WAS INVOLVED, NO EVIDENCE OF INCORPORATION. A SMALL PIECE OF THE EXPLANTED GRAFT WILL BE RETURNED.

  Patient problems: Seroma

  MAUDE report 18623683 ↗
• InjuryAug 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2023, A PATIENT UNDERWENT A RIGHT AXILLOPOPLITEAL BYPASS FOR A FINAL ATTEMPT TO SALVAGE THE LOWER LIMB UTILIZING TWO GORE® PROPATEN® VASCULAR GRAFTS. IT WAS REPORTED THE TWO 6 MM BY 80 CM GRAFTS WERE SEWN TOGETHER AND IMPLANTED. REPORTEDLY, THE PATIENT WAS DOING FINE POSTOPERATIVELY. POST OP CT SCAN FOLLOWING THE ORIGINAL SURGERY LOOKED FAVORABLE. THREE MONTHS POSTOP, ON AN UNKNOWN DATE, THE PATIENT WAS PICKING UP A BACKPACK AND FELT A "POP". A REINTERVENTION PROCEDURE WAS PERFORMED. REPORTEDLY, ALL THE ANASTOMOSES WERE STILL INTACT, BUT ONE OF THE GRAFTS, APPROXIMATELY 2 CM DISTAL TO THE GRAFT-TO-GRAFT ANASTOMOSIS WAS CIRCUMFERENTIALLY TORN. IT IS UNKNOWN WHICH OF THE TWO GRAFTS RUPTURED. THE GRAFT WAS LIGATED TO STOP THE BLEEDING, AND A VIABAHN DEVICE WAS IMPLANTED. THE PATIENT WILL EVENTUALLY HAVE AN AMPUTATION PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17589433 ↗
• DeathFeb 12, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PRESENTED FOR AXILLOFEMORAL BYPASS USING A GORE® PROPATEN® VASCULAR GRAFT. IT WAS REPORTED TEN DAYS POST OPERATIVE THE PATIENT EXPIRED. THE PHYSICIAN STATED THE PATIENT EXPIRED DUE TO MULTI ORGAN FAILURE AND HEMORRHAGIC SHOCK. THE PHYSICIAN ALSO STATED THE MULTI ORGAN FAILURE AND HEMORRHAGIC SHOCK WAS SUSPECTED TO HAVE BEEN CAUSED BY A COMPLETE TRANSECTION/DISRUPTION OF THE PROXIMAL END OF THE GRAFT 4CM DISTAL TO THE ANASTOMOSES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11323226 ↗
• InjuryFeb 5, 2021Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE (7MONTHS AGO) A GORE® PROPATEN® VASCULAR GRAFT (VG) WAS PLACED IN THE SUPERFICIAL FEMORAL ARTERY FOR TREATMENT OF OCCLUSION. ON (B)(6) 2021, A GORE® VIABAHN® ENDOPROSTHESIS (VSX) WAS PLACED IN THE COMMON ILIAC FOR TREATMENT OF STENOSIS. THE PHYSICIAN WAS UNABLE TO GAIN ACCESS IN THE UPPER ARM DUE TO THE DISEASED STATE OF THE PATIENT'S VESSELS. SO THE PHYSICIAN DECIDED TO GAIN ACCESS FROM THE VG THAT WAS PREVIOUSLY IMPLANTED (ON AN UNKNOWN DATE). THE PHYSICIAN CUT DOWN INTO THE VG AND INSERTED A 7FR INTRODUCER SHEATH. THE VSX WAS SUCCESSFULLY DEPLOYED IN THE NATIVE VESSEL ABOVE THE VG DEVICE IN THE COMMON ILIAC. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. ON (B)(6) 2021, THE PATIENT HAD LOW ANKLE-BRACHIAL INDEX (ABI) AND AN ULTRA SOUND WAS PERFORMED. IT WAS NOTICED THAT THE LOW ABI WAS COMING FROM THE VG AND WHAT APPEARED TO BE A SEPARATION OF THE GRAFT'S INNER LUMEN. ON (B)(6) 2021, THE DECISION WAS MADE TO RELINE THE VG WITH A 6MM X 25CM VSX. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 11289408 ↗
• InjuryJan 19, 2021Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE IN THE FEMORAL ARTERIES AND UNDERWENT AN AORTOBIFEMORAL BYPASS UTILIZING A GORE® PROPATEN® VASCULAR GRAFT. THE PHYSICIAN COMPLETED THE IMPLANTING PROCEDURE SUCCESSFULLY. WHILE THE PATIENT WAS IN POST OPERATIVE RECOVERY, IT WAS OBSERVED THAT THE PATIENT WAS BLEEDING AND WAS TAKEN BACK TO THE OPERATING ROOM. THE PHYSICIAN OBSERVED THAT THE GORE® PROPATEN® VASCULAR GRAFT APPEARED TORN FROM THE ANASTOMOSIS IN THE PROFUNDA POST OPERATIVELY. THE PHYSICIAN MADE THE FOLLOWING OBSERVATIONS: PART OF THE GORE® PROPATEN® VASCULAR GRAFT WAS STILL CONNECTED TO THE ARTERY, AND WHEN THE GORE® PROPATEN® VASCULAR GRAFT REPORTEDLY BROKE IT RETRACTED BACK INTO THE TUNNEL THAT WAS CREATED FOR PLACEMENT. THE PHYSICIAN THEN DECIDED TO LIGATE THE GORE® PROPATEN® VASCULAR GRAFT AND CLOSED OFF THE PROFUNDA. THE PROCEDURE WAS COMPLETED BY PERFORMING AN ABOVE KNEE AMPUTATION. THE PATIENT TOLERATED THE PROCEDURE AND IS REPORTED TO BE RECOVERING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 11194486 ↗
• InjurySep 15, 2020Contamination; Contamination

  ON (B)(6) 2020, AN GORE® PROPATEN® VASCULAR GRAFT (STANDARD WALL REMOVABLE RINGS AX-BIFEM) WAS IMPLANTED DUE TO AORTA-ILIAC OCCLUSIVE DISEASE. ON (B)(6) 2020, THE GRAFT WAS EXPLANTED BECAUSE OF A REPORTED GRAFT INFECTION. THE PATIENT WAS DIAGNOSED WITH MRSA SOMETIME AFTER THE VASCULAR GRAFT WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE RECOVERING WELL AFTER THE EXPLANT PROCEDURE. THE EXPLANTED GRAFT WAS DISCARDED AND A SECTION OF THE GRAFT WAS SENT FOR TESTING AT THE USER FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 10538881 ↗
• InjuryJun 19, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020 THE PATIENT WAS IMPLANTED WITH A GORE® PROPATEN® VASCULAR GRAFT FOR AV ACCESS IN THE LEFT COMMON ILIAC ARTERY. ON AN UNKNOWN DATE, DELAMINATION OF THE GRAFT WAS REPORTEDLY IDENTIFIED. ON (B)(6), THE GORE® PROPATEN® VASCULAR GRAFT WAS SURGICALLY REMOVED FROM THE PATIENT IN MULTIPLE PIECES.

  Patient problems: No Code Available

  MAUDE report 10176855 ↗
• InjuryMay 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO GORE: A BYPASS WAS PERFORMED WITH A 6 MM GORE® PROPATEN® VASCULAR GRAFT IN THE MORNING, AND CLOTTED IN THE AFTERNOON. THE PHYSICIAN WENT IN FOR REVISION OF THE GRAFT AT THE TIBIAL ARTERY, THE DOCTOR MENTIONED THE ARTERY WAS SMALL BUT DID NOT INDICATE THE SIZE OF THE ARTERY DIAMETER. HE PLACED A STENT (UNKNOWN DEVICE) AT THE TIBIAL ARTERY. DOCTOR MENTIONED THAT ONLY A SMALL PORTION OF THE PROPATEN® VASCULAR GRAFT WAS EXPOSED TO THE BLOOD STREAM AT THE FEMORAL ARTERY DUE TO THE ADDITIONAL STENT PLACEMENT. THE PATIENT RECEIVED 6000 IU AT THE BEGINNING OF THE PROCEDURE, THEN 2000IU ABOUT 45 MINUTES LATER DURING THE PROCEDURE (IT WAS NOT CLEAR IF HE MEANT INITIAL PROCEDURE OR DE-CLOT/STENT PROCEDURE), DOCTOR STARTING SEEING CLOT AFTER 8000 IU OF SYSTEMIC HEPARIN HAD BEEN GIVEN. HE SAW CLOT IN THE FIELD AND THROMBUS IN THE GRAFT AGAIN, THROMBUS IN THE GRAFT WAS NOTED AS WHITE CLOT, WHICH COULD BE DOCTOR KNEW TO BE INDICATIVE OF HIT. HE BEGAN THE CESSATION OF SYSTEMIC HEPARIN AND PLACED PATIENT ON AGATROBAN®. HAS A HEMATOLOGIST ON THE CASE; SENT OUT A HIT PANEL, BUT DOES NOT HAVE RESULTS YET. PATIENT PLATELETS WERE INITIALLY 189,000, THREE DAYS LATER WERE MEASURED AT 13

  Patient problems: No Code Available; Thrombus

  MAUDE report 10059578 ↗
• DeathFeb 27, 2020Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019 AN 8MM GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED AS A BYPASS, COMMON ILIAC TO DISTAL SFA. ON (B)(6) 2020 THE PHYSICIAN PERFORMED A RE-EXPLORATION AS A RESULT OF AN IDENTIFIED OCCLUSION WITHIN THE GRAFT. THE DOCTOR PERFORMED A GRAFT THROMBECTOMY AS WELL AS REVISION OF THE DISTAL ANASTOMOSIS, EXTENDING TREATMENT BY SEWING A SECOND GRAFT TO THE DISTAL ANASTOMOSIS TO THE POPLITEAL BELOW KNEE POSITION. ON (B)(6) THE GRAFT TO GRAFT ANASTOMOSIS DISRUPTED. ACCORDING TO THE DOCTOR, THE PATIENT BLED OUT VERY RAPIDLY AND EXPIRED.

  Patient problems: Death

  MAUDE report 9764624 ↗
• DeathFeb 10, 2020Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(4) 2019 AN 8MM GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED AS A BYPASS, COMMON ILIAC TO DISTAL SFA. ON (B)(6) 2020 THE PHYSICIAN PERFORMED A RE-EXPLORATION AS A RESULT OF AN IDENTIFIED OCCLUSION WITHIN THE GRAFT. THE DOCTOR PERFORMED A GRAFT THROMBECTOMY AS WELL AS REVISION OF THE DISTAL ANASTOMOSIS, EXTENDING TREATMENT BY SEWING A SECOND GRAFT TO THE DISTAL ANASTOMOSIS TO THE POPLITEAL BELOW KNEE POSITION. ON (B)(6) THE GRAFT TO GRAFT ANASTOMOSIS DISRUPTED. ACCORDING TO THE DOCTOR, THE PATIENT BLED OUT VERY RAPIDLY AND EXPIRED.

  Patient problems: Death

  MAUDE report 9689891 ↗
• InjuryOct 22, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, A GORE® PROPATEN® VASCULAR GRAFT (STANDARD-WALLED, AXILLOBIFEMORAL, REMOVABLE RINGED) WAS IMPLANTED USING A GORE TUNNELER. AROUND (B)(6) 2019 (REPORTED AS 6-8 WEEKS AGO), PATIENT RECEIVED TREATMENT DUE TO SEROMA. CLEAR FLUID WAS DRAINED. ANOTHER INTERVENTION WAS PERFORMED AFTER (B)(6) (DATE UNSPECIFIED) AND CLEAR FLUID WAS DRAINED AGAIN. AS REPORTED, FLUID WAS TESTED EACH TIME. CULTURES WERE NEGATIVE FOR INFECTION AND THERE WAS NO BLOOD IN THE ASPIRATED FLUID. ON (B)(6) 2019, PATIENT PRESENTED WITH SEROMA AND CLEAR FLUID WAS DRAINED AGAIN. DURING THIS INTERVENTION, THE VASCULAR GRAFT WAS RELINED ALMOST ENTIRELY WITH SEVERAL GORE® VIABAHN® ENDOPROSTHESES. BEFORE IMPLANTATION, CAT SCAN MEASUREMENTS WERE TAKEN TO ENSURE CORRECT SIZING. IT WAS REPORTED ONLY A 4 CM SEGMENT WAS LEFT UNLINED. A DRAINAGE TUBE WAS LEFT IN PLACE. PATIENT WAS REPORTED TO BE RECOVERING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Seroma

  MAUDE report 9221646 ↗
• InjuryOct 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO GORE: THE GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2019 IN THE GROIN. ON (B)(6) 2019 THE DEVICE WAS EXPLANTED BECAUSE OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9158382 ↗

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