GORE-TEX Vascular Graft SRRT06060080LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132612383), received between Aug 17, 2022 and Jul 10, 2024 — classified as 9 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2024Complete Blockage; Device Stenosis; Complete Blockage; Device Stenosis

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE FROM THIRD PARTY: ON (B)(6) 2024, THE PATIENT PRESENTED WITH A COMPROMISED RIGHT LOWER LIMB DUE TO SEVERE CHRONIC ISCHEMIA. ON THE SAME DAY, IN AN ATTEMPT TO SAVE THE LIMB, A GORE-TEX® STRETCH VASCULAR GRAFT (GRAFT) WAS IMPLANTED AS A PROSTHETIC RIGHT FEMORO-TIBIAL BYPASS TO TREAT ISCHEMIA. ON THE SAME DAY, THE PATIENT UNDERWENT RIGHT TRANSFEMORAL AMPUTATION BECAUSE OF ACUTE ISCHEMIA. IT WAS REPORTED THAT A SEGMENT OF THE GRAFT WAS EXPLANTED FROM THE AMPUTATED LOWER LIMB. REPORTEDLY THIS GRAFT SEGMENT APPEARED TO BE THROMBOSED. IT WAS MENTIONED BY THE SURGEON THAT GRAFT THROMBOSIS WAS MOST PROBABLY CAUSED BY INSUFFICIENT BLOOD FLOW PER MINUTE THROUGH THE GRAFT DUE TO GENERAL CRITICAL ISCHEMIA. BECAUSE OF GENERAL CRITICAL ISCHEMIA AND BECAUSE THE LOWER LIMB WAS ALREADY COMPROMISED, THEY DECIDED AGAINST A FURTHER MINIMAL-INVASIVE PROCEDURE TO RE-ESTABLISH BLOOD FLOW THROUGH THE GRAFT AND INSTEAD AMPUTATED THE LOWER LIMB.

  Patient problems: Ischemia; Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 19712398 ↗
• InjuryJun 17, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR AN ACUTE ISCHEMIA IN THE LEFT LOWER LIMB WITH A GORE-TEX® STRETCH VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED. THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2023, AS A BYPASS BETWEEN THE SUPRA-ARTICULAR POPLITEAL ARTERY AND THE SUB-ARTICULAR POPLITEAL ARTERY OF THE LEFT LOWER LIMB IN ORDER TO TREAT AN ACUTE ISCHEMIA WITH SENSITIVOMOTOR DISORDERS. AN ABSCESS WAS NOTED ON THE POPLITEAL FOSSA. ON (B)(6) 2024, AFTER APPROXIMATELY 1 MONTH, THE PROSTHESIS WAS EXPLANTED DUE TO A PSEUDOMONAS INFECTION. DURING THE SAME PROCEDURE, A FEMOROPOPLITEAL BYPASS USING AN ARTERIAL ALLOGRAFT WAS IMPLANTED. THE PATIENT WAS AUTHORISED TO RETURN HOME ON (B)(6) 2024.

  Patient problems: Bacterial Infection

  MAUDE report 19545255 ↗
• InjurySep 5, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO GORE THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR ISCHEMIA EXCEEDED AT THE LEVEL OF THE LEFT LOWER LIMB WITH NECROSIS GOING UP ABOVE THE ANKLE. A LEFT TRANS-FEMORAL AMPUTATION WAS PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, A RIGHT ILIO-FEMORO-POPLITEAL-LEG THROMBECTOMY WAS PERFORMED ASSOCIATED WITH A GORE PROSTHETIC SUB-ARTICULAR FEMORO-POPLITEAL BYPASS (GORE-TEX® STRETCH VASCULAR GRAFT THIN WALL REMOVABLE RINGS) OF THE RIGHT LOWER LIMB TO TREAT THE CRITICAL ISCHEMIA. IT WAS STATED THAT ON (B)(6) 2023, DUE TO A THROMBOSIS, A NEW SURGICAL TREATMENT WAS PERFORMED FOLLOWING OBLITERATION OF THE GORE BYPASS AND THE ILIAC AXIS UPSTREAM. ABLATION OF THE THROMBOSED BYPASS WAS PERFORMED ASSOCIATED WITH REPAIR OF THE FEMORAL TRIPOD WITH PATCH, THROMBECTOMY AND STENTING ANGIOPLASTY OF THE RIGHT EXTERNAL ILIAC ARTERY. A FEMORO-FIBULAR BYPASS WITH THE GREAT SAPHENOUS VEIN IN SITU WAS PERFORMED AND A VASCULAR PERICARDIUM PATCH WAS IMPLANTED ON BOTH BRANCHES OF THE DEEP AND CIRCUMFLEX FEMORAL ARTERIES. EXTERNAL ILIAC ARTERY ANGIOPLASTY WAS ALSO PERFORMED AND THE POST-OPERATIVE FOLLOW-UP WAS SIMPLE WITHOUT AGGRAVATION. THE PATIENT RETURNED HOME ON (B)(6) 2023.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17682047 ↗
• InjurySep 5, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO GORE THAT THE PATIENT PRESENTED URGENTLY TO THE VASCULAR SURGERY DEPARTMENT BY HIS ANGIOLOGIST ON (B)(6) 2023, WITH WORSENING PAIN IN THE RIGHT LOWER LIMB WITH NO TROPHIC DISORDERS OR SENSORY-MOTOR DEFICITS. ON (B)(6) 2023, A THROMBO-EMBOLECTOMY OF THE SUPERFICIAL FEMORAL ARTERY AND THE RIGHT POPLITEAL ARTERY WAS PERFORMED. ON (B)(6) 2023, THE PATIENT PRESENTED WITH ACUTE ISCHAEMIA AND MOTOR DEFICIT OF THE RIGHT LOWER LIMB AND UNDERWENT A PROSTHETIC SUB-ARTICULAR FEMORO-POPLITEAL BYPASS WITH A GORE-TEX® STRETCH VASCULAR GRAFT THIN WALLED REMOVABLE RINGS. ON (B)(6) 2023, A FOLLOW-UP DOPPLER ULTRASOUND REVEALED OBSTRUCTION OF THE BYPASS AT ITS ORIGIN. THROMBECTOMY OF THE FEMORO-POPLITEAL BYPASS COMBINED WITH ANGIOPLASTY OF THE RIGHT ANTERIOR TIBIAL ARTERY WAS PERFORMED. THE POST-OPERATIVE FOLLOW-UP WAS UNFAVOURABLE, WITH THE LEG REMAINING ISCHAEMIC AND DEFICIENT. AMPUTATION WAS THEREFORE DECIDED ON (B)(6) 2023. AFTER AMPUTATION, THE PATIENT PRESENTED WITH AN EPISODE OF RECTAL BLEEDING AND ACUTE RENAL FAILURE. HE, WAS THEN TRANSFERRED TO A RE-EDUCATION AND FUNCTIONAL REHABILITATION ESTABLISHMENT AND THEN TO AN ESTABLISHMENT FOR THE ELDERLY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17681873 ↗
• InjuryAug 30, 2023Microbial Contamination of Device; Microbial Contamination of Device

  A STUDY ALERT FROM THE PVG 21-01 CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT FOR AN OCCLUSIVE PERIPHERAL ARTERY DISEASE IN WHICH A GORE-TEX® STRETCH VASCULAR GRAFT WAS USED AS A BYPASS FOR A FEMORO-PERONEAL PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. REPORTEDLY, THE WHOLE PROCEDURE WAS UNEVENTFUL, VASCULAR ACCESS WAS SUCCESSFULLY GAINED, DEVICE DEPLOYED AS INTENDED, CATHETER WAS SUCCESSFULLY REMOVED AND THE PATENCY OF THE DEVICES WERE CONFIRMED AT THE END OF THE PROCEDURE. THE PATIENT RECEIVED AN ADDITIONAL ANTIPLATELET MEDICATION DURING THE PROCEDURE. REPORTEDLY ON (B)(6) 2018 A GRAFT INFECTION WAS DISCOVERED, THIS WAS A RECORDED AS DEVICE-RELATED. AN UNSPECIFIED REINTERVENTION WAS ADMINISTERED AND THE PATIENT REQUIRED WITHOUT A SEQUELAE.

  Patient problems: Bacterial Infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649094 ↗
• InjuryAug 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT PRESENTED WITH A CRITICAL LIMB THREATENING ISCHEMIA DUE TO AN OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY HAS BEEN TREATED WITH A GORE-TEX® STRETCH VASCULAR GRAFT ON (B)(6) 2023. REPORTEDLY IN VIEW OF THE DEPTH AND EXTENT OF THE WOUNDS AND DUE TO THE VERY HIGH RISK OF A RAPID ADVERSE AND LIFE-THREATENING OUTCOME THE GRAFT WAS EXPLANTED DURING A MAJOR AMPUTATION ON (B)(6) 2023. FURTHERMORE IT WAS REPORTED THAT THE AMPUTATION WAS NOT ASSOCIATED WITH OCCLUSION/THROMBOSIS OF THE GRAFT.

  Patient problems: Insufficient Information; Ischemia

  MAUDE report 17628924 ↗
• InjuryAug 10, 2023Microbial Contamination of Device; Obstruction of Flow; Microbial Contamination of Device; Obstruction of Flow

  GORE RECEIVED AN ADVERSE EVENT ALERT FROM A RETROSPECTIVE VASCULAR GRAFT STUDY. IT WAS REPORTED THAT, ON (B)(6) 2015, THE PATIENT PRESENTED WITH AN OCCLUSION IN THE RIGHT LEG DUE TO PERIPHERAL ARTERY DISEASE (PAD, FONTAINE SCALE IV - ULCERATION OR GANGRENE) AND UNDERWENT SURGICAL TREATMENT WITH A GORE-TEX® VASCULAR GRAFT USED AS A FEMORO-POPLITEAL BYPASS. REPORTEDLY THERE WAS NO PRE-EXISTING INFECTION IN THE FIELD OF TREATMENT. HEPARIN WAS USED DURING THE PROCEDURE. THE GRAFT WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2015, THE PATIENT PRESENTED WITH DEHISCENCE OF THE INCISION SCAR AT THE ACCESS SITE WITHOUT THE GRAFT BEING EXTERNALLY EXPOSED. REPORTEDLY THE CAUSE FOR DEHISCENCE WAS INFECTION OF THE INCISION SITE BECAUSE OF CHRONIC SEPSIS OF AN ABDOMINAL PLAQUE AND UNDERNOURISHMENT. THE INFECTION OF THE INCISION SITE WAS REPORTEDLY RELATED TO THE PROCEDURE. THE INFECTION HAS SPREAD AND LED TO GRAFT INFECTION AND SEPTIC THROMBOSIS OF THE GRAFT SECONDARY TO GRAFT INFECTION. IT WAS REPORTED THAT BACTERIOLOGICAL TESTING CONFIRMED BACTERIAL INFECTION OF THE GRAFT. ON (B)(6) 2015, THE GRAFT WAS EXPLANTED DUE TO INFECTION AND THROMBOSIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 3 WEEKS. RE

  Patient problems: Bacteremia; Bacterial Infection; Post Operative Wound Infection; Thrombosis/Thrombus

  MAUDE report 17499226 ↗
• InjuryFeb 10, 2023Microbial Contamination of Device; Microbial Contamination of Device

  REPORTEDLY, THE PATIENT UNDERWENT SURGICAL TREATMENT WITH A GORE-TEX® VASCULAR GRAFT. IT WAS RECORDED THAT THE VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2022, AS A FEMORAL-POPLITEAL BYPASS DUE TO A PERIPHERAL ARTERY DISEASE. REPORTEDLY, ON (B)(6) 2022, AFTER 11 DAYS, THE GRAFT WAS EXPLANTED DUE TO AN INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 16349376 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR A FEMOROTIBIAL BYPASS WITH A GORE-TEX® STRETCH VASCULAR GRAFT THIN-WALLED REMOVABLE RINGED. IT WAS STATED THAT THE VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2021, IN EMERGENCY SETTING FOR AN ACUTE LIMB ISCHEMIA RUTHERFORD IIB DUE TO A PET BYPASS THROMBOSIS. REPORTEDLY, ON (B)(6) 2021, AFTER ABOUT 11 YEARS FOR THE PET PROSTHESIS AND 3 DAYS FOR THE VASCULAR GRAFT, BOTH DEVICES WERE EXPLANTED DURING MAJOR AMPUTATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15239491 ↗