GORE PROPATEN Vascular Graft HT066080ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132606641), received between Feb 5, 2021 and Nov 25, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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, 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 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 ↗
• 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 ↗
• 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 ↗