GORE-TEX Vascular Graft RRT06060080LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132610945), received between Oct 2, 2020 and Mar 28, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, A GORE-TEX® VASCULAR GRAFT GRAFT (THIN-WALLED, REMOVABLE RINGS) WAS IMPLANTED IN A BYPASS PROCEDURE, FROM THE AXILLARY ARTERY TO THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). DURING A FOLLOW-UP ON (B)(6) 2023, THE IMAGING SCAN SHOWED THE VASCULAR GRAFT APPEARANCE WAS NORMAL. AS REPORTED, THE PHYSICIAN WAS NOT AWARE OF ANY TRAUMA THE PATIENT EXPERIENCED. THE PHYSICIAN DID SPECULATE IT WAS POSSIBLE THE ILIAC CREST WAS RUBBING ON THE VASCULAR GRAFT, LEADING TO SOME DETERIORATION. IT WAS ALSO POSSIBLE THE PATIENT CHANGED SLEEPING POSITIONS WHICH CAUSED THE VASCULAR GRAFT TO DEGRADE. DURING A FOLLOW-UP ON (B)(6) 2024, IMAGING SHOWED THE 6MM GORE-TEX® VASCULAR GRAFT APPEARED TO BE DISRUPTED IN THE DISTAL TO MID-SECTION. AS REPORTED, THE PATIENT WAS ASYMPTOMATIC. RE-INTERVENTION WAS PLANNED FOR A LATER DATE. ON (B)(6) 2024, THE RE-INTERVENTION WAS PERFORMED. AN 8X25 GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED TO COVER THE DISRUPTED SECTION OF THE GORE-TEX® VASCULAR GRAFT. PATIENT WAS RECOVERING WELL FOLLOWING THE SUCCESSFUL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000310 ↗
• InjuryJun 29, 2023Complete Blockage; Complete Blockage

  ON (B)(6) 2014, A STUDY PATIENT WAS IMPLANTED WITH A GORE-TEX® VASCULAR GRAFT (REGISTRY DEVICE) DUE TO OCCLUSIVE DISEASE. THE REGISTRY DEVICE WAS IMPLANTED FROM THE RIGHT COMMON FEMORAL ARTERY TO THE POPLITEAL ARTERY (BELOW KNEE). ON (B)(6) 2014, THE PATIENT PRESENTED WITH THROMBUS AT THE PROXIMAL ANASTOMOSIS, THE RIGHT ILIAC ARTERY AND RIGHT PROFUNDA. A PROCEDURE-RELATED ACUTE HEMORRHAGE AT THE NEEDLE-PUNCTURE SITE OF THE RIGHT FEMORO-POPLITEAL BYPASS WAS ALSO OBSERVED ON THE SAME DAY. ON (B)(6) 2014, AN OPEN REPAIR WAS PERFORMED WITH ADJUNCTIVE DEVICES. DEVICE PATENCY WAS RESTORED AT END OF THE PROCEDURE. THE REPORTED ISSUE OF THROMBUS WAS RESOLVED WITHOUT SEQUELAE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17232498 ↗
• InjuryJun 17, 2023Microbial Contamination of Device; Microbial Contamination of Device

  ON (B)(6) 2014, THIS STUDY SUBJECT UNDERWENT AN ENDOVASCULAR PROCEDURE ON THE RIGHT LOWER LIMB DUE TO A PERIPHERAL ARTERY DISEASE WITH A GORE-TEX® VASCULAR GRAFT. THE PROXIMAL AND DISTAL ANASTOMOSIS WERE SPECIFIED TO BE IN THE COMMON FEMORAL AND POPLITEAL ARTERIES RESPECTIVELY. REPORTEDLY THE PROCEDURE WAS UNEVENTFUL, AND THE GRAFT WAS PATENT AT THE END OF THE PROCEDURE. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT PRESENTED WITH REPORTED ADVERSE EVENT TERMED "INFECTION OF THE RIGHT FEMORO-POPLITEAL GORE BYPASS". REPORTEDLY A REINTERVENTION WAS PERFORMED (NOT FURTHER SPECIFIED). THE OUTCOME OF THE ADVERSE EVENT WAS RECORDED AS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Bacterial Infection; Post Operative Wound Infection; Purulent Discharge

  MAUDE report 17149191 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: REPORTEDLY ON (B)(6), 2014, THIS PATIENT UNDERWENT A PROCEDURE FOR THE TREATMENT OF AN OCCLUSIVE PERIPHERAL ARTERIAL DISEASE IN WHICH A GORE-TEX® VASCULAR GRAFT WAS USED AS A BYPASS (FEMORO-TIBIAL BYPASS). REPORTEDLY, THE WHOLE PROCEDURE WAS UNEVENTFUL, ACCESS WAS SUCCESSFULLY GAINED, DEVICE DEPLOYED AS INTENDED, CATHETERS WERE SUCCESSFULLY REMOVED AND THE PATENCY OF THE DEVICE WAS CONFIRMED AT THE END OF THE PROCEDURE. THE PATIENT RECEIVED HEPARIN DURING THE PROCEDURE. ACCORDING TO REPORTS, ON (B)(6), 2014 AN ADVERSE EVENT TERMED " THROMBOSIS OF THE GORE LEFT FEMORO TIBIAL ANTERIOR BYPASS" WAS DISCOVERED. THE RELATIONSHIP WAS RECORDED AS DISEASE-RELATED AND IT WAS RECORDED THAT THE ADVERSE EVENT REQUIRED TREATMENT.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16834225 ↗
• InjuryNov 3, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO GORE THAT PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A BILATERAL CRITICAL LIMB ISCHEMIA. A RIGHT FEMORO-POPLITEAL BYPASS WAS MADE ON (B)(6) 2019 USING A GORE-TEX® VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED. IT WAS STATED THAT ON (B)(6) 2019 A THROMBECTOMY OF THE RIGHT FEMORO-POPLITEAL BYPASS WAS PERFORMED, DUE TO ACUTE THROMBOSIS. HOWEVER, RIGHT THIGH AMPUTATION WAS REQUIRED DUE TO UNFAVORABLE LOCAL EVOLUTION ON (B)(6) 2019.

  Patient problems: Thrombosis

  MAUDE report 10778571 ↗
• InjuryOct 2, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED TO GORE THAT PATIENT UNDERWENT ENDOVASCULAR TREATMENT ON (B)(6) 2019 FOR A FEMORO-ANTERIO-TIBIAL BYPASS (EXTRA-ANATOMIC) IN ORDER TO TREAT A HIGHLY ADVANCED RIGHT LIMB CRITICAL ISCHEMIA, WITH SUPERINFECTED MAJOR TROPHIC DISORDERS, BY USING A GORE-TEX® VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED. IT WAS STATED THAT THE BYPASS THROMBOSED RAPIDLY AND IN FRONT OF THE VERY IMPORTANT TROPHIC DISORDERS (PAINFUL AND SUPERINFECTED) AND DESPITE REVASCULARIZATION, IT WAS DECIDED TO PERFORM A THIGH AMPUTATION THREE DAYS LATER. REPORTEDLY, THE PROSTHESIS WAS SENT FOR ANALYSIS.

  Patient problems: Ischemia

  MAUDE report 10620266 ↗