GORE-TEX Stretch Vascular Graft S0604Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132611294), received between Oct 18, 2019 and Oct 16, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Compatibility Problem” (1 report).

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2023Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  GORE RECEIVED AN ADVERSE EVENT ALERT FROM A RETROSPECTIVE VASCULAR GRAFT STUDY. ON JUNE 4, 2019, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR THE CREATION OF A VASCULAR ACCESS GRAFT FOR HEMODIALYSIS BRACHIO-BASILIC IN THE LEFT ARM WITH A GORE-TEX® STRETCH VASCULAR GRAFT. THE DEVICE WAS IMPLANTED AND RETAINED AND THERE WERE NO ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME TWO DAYS LATER. ON (B)(6) 2019, THE PATIENT PRESENTED WITH A VASCULAR STEAL SYNDROME WHICH NEEDS MEDICAL OR SURGICAL INTERVENTION. THE ISSUE WAS RESOLVED ON (B)(6) 2019, BY CLOSING OF THE LEFT BRACHIO-BASILIC PROSTHETIC LINE. THE FULL DEVICE WAS EXPLANTED AS PART OF THE REINTERVENTION. AS PRIMARY RELATIONSHIP PROCEDURE-RELATED WAS MENTIONED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Ischemia

  MAUDE report 17937970 ↗
• InjurySep 4, 2023Contamination; Contamination

  GORE RECEIVED AN ADVERSE EVENT ALERT FROM A RETROSPECTIVE VASCULAR GRAFT STUDY. ON (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR THE CREATION OF A VASCULAR ACCESS GRAFT BRACHIO-BASILIC IN THE LEFT ARM FOR HEMODIALYSIS WITH A GORE-TEX® STRETCH VASCULAR GRAFT, BECAUSE OF AN ACCESS SITE INFECTION OF A JUGULAR CATHETER. THE DEVICE WAS IMPLANTED AND RETAINED AND THERE WERE NO ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2016, AND THE FIRST ORDER TO DIALYZE THROUGH THE GRAFT SUCCESSFULLY WAS ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT PRESENTED WITH AN INFECTION OF THE PROSTHETIC LOOP GRAFT. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED, AND TREATMENT REQUIRED. THE ISSUE WAS RESOLVED ON (B)(6) 2016. THE STUDY WAS DISCONTINUED, AS THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17676110 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR THE CREATION OF A VASCULAR ACCESS GRAFT FOR HEMODIALYSIS WITH A GORE-TEX® STRETCH VASCULAR GRAFT. DURING THE PROCEDURE ANTICOAGULANT / ANTIPLATELET WAS USED AND THE DEVICE WAS IMPLANTED AND RETAINED SUCCESSFULLY. ON (B)(6) 2019, AN ADVERSE EVENT TERMED HEMATOMA AFTER THE CREATION OF HUMERO-AXILLARY PROSTHETIC LINE WAS DISCOVERED AND THE PRIMARY RELATIONSHIP WAS RECORDED AS PROCEDURE RELATED. A REINTERVENTION IN THE FORM OF A REVISION SURGERY WAS PERFORMED AND THE PATIENT RECOVERED WITHOUT A SEQUELEA. ACCORDING TO REPORTS ON (B)(6) 2020, ANOTHER ADVERSE EVENT TERMED FALSE ANEURYSM ON THE RIGHT PROSTHETIC HUMERO AXILLARY LINE WAS RECORDED. THE PRIMARY RELATIONSHIP WAS RECORDED AS DISEASE RELATED AND THE PATIENT RECOVERED WITHOUT A SEQUELEA AFTER AN UNSPECIFIED REINTERVENTION WAS PERFORMED.

  Patient problems: Aneurysm; Hematoma; Pseudoaneurysm

  MAUDE report 17649120 ↗
• InjuryJul 24, 2023Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2018, A GORE-TEX® STRETCH VASCULAR GRAFT (VASCULAR GRAFT) WAS IMPLANTED IN A STUDY PATIENT IN A DIALYSIS ACCESS APPLICATION. THE IMPLANT WAS IN THE PATIENT'S LEFT ARM, FROM THE BRACHIAL ARTERY TO CEPHALIC VEIN. ON (B)(6) 2018, THE VASCULAR GRAFT WAS REPORTEDLY ABANDONED DUE TO REPEATED THROMBOSIS. DATE(S) OF THROMBOSIS WERE NOT PROVIDED. ON (B)(6) 2018, A RIGHT BRACHIAL TO CEPHALIC ARTERIOVENOUS FISTULA WAS CREATED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17383414 ↗
• InjuryJul 20, 2023Partial Blockage; Partial Blockage

  FROM A CLINICAL STUDY THE FOLLOWING INFORMATION WAS OBTAINED: ON (B)(6) 2018, A GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED IN A DIALYSIS ACCESS APPLICATION. THE IMPLANT WAS IN THE STUDY PATIENT'S LEFT ARM (BRACHIAL TO BRACHIAL). ON (B)(6) 2018, THROMBOSIS OF THE VASCULAR GRAFT (PROSTHETIC LINE) WAS REPORTED. INTERVENTION WAS PERFORMED. THE REPORTED ISSUE WAS LISTED AS DISEASE-RELATED AND RESOLVED WITHOUT SEQUELAE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17358236 ↗
• InjuryJul 5, 2023Complete Blockage; Complete Blockage

  REPORTEDLY ON (B)(6) 2023, THIS PATIENT UNDERWENT SURGICAL TREATMENT WITH A GORE-TEX® STRETCH VASCULAR GRAFT IN ORDER TO CREATE A HEMODYLIASIS ACCESS. THE ACCESS CONFIGURATION WAS RECORDED TO BE A RIGHT HAND HUMORO-AXILLARY BYPASS. IT WAS RECORDED THAT ON THE SAME DAY, AN ADVERSE EVENT TERMED "EARLY THROMBOSIS" WAS DISCOVERED AND REINTERVENTION WAS PERFORMED. THE PATIENT RECOVERED WITHOUT A SEQUALAE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17261604 ↗
• InjuryAug 17, 2020Compatibility Problem; Compatibility Problem

  ON (B)(6) 2020, A GORE® PROPATEN® VASCULAR GRAFT WAS PLACED AS A ARTERIOVENOUS GRAFT (AVG) FOR HEMODIALYSIS IN THE UPPER ARM. AFTER THE DEVICE WAS IMPLANTED IT WAS NOTICED THAT THE PATIENT DEVELOPED SWELLING. THE DEVICE WAS EXPLANTED AT THE TIME OF THE PROCEDURE. THE PHYSICIAN SUSPECTED THE GRAFT HAD SOME HYPERFILTRATION, DUE TO PROTEINACEOUS PEEL, WHICH CAUSED THE SWELLING. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available; Seroma

  MAUDE report 10417771 ↗
• InjuryOct 18, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH A GORE-TEX® STRETCH VASCULAR GRAFT - STANDARD-WALLED IN THE RIGHT ARM. THE DEVICE WAS REPORTEDLY USED FOR THE APPLICATION OF AV ACCESS. IT IS UNKNOWN IF THE DEVICE WAS PRE-CANNULATED FOR AV ACCESS. THERE WAS REPORTEDLY NO PRE-EXISTING INFECTION AT IMPLANT SITE. ON (B)(6) 2019, THE DEVICE WAS REPORTEDLY EXPLANTED DUE TO INFECTION. THE PHYSICIAN REPORTEDLY STATED IT IS UNKNOWN IF THE CAUSE OF THE INFECTION IS ATTRIBUTED TO THE GORE DEVICE.

  Patient problems: Unspecified Infection

  MAUDE report 9211013 ↗