GORE-TEX Vascular Graft RRT08070080LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132611102), received between Oct 2, 2020 and Jul 5, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Contamination” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2023Microbial Contamination of Device; Microbial Contamination of Device

  REPORTEDLY ON (B)(6) 2014, THIS PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR AN EXTENSIVE OCCLUSIVE PERIPHERAL ARTERIAL DISEASE IN WHICH A GORE-TEX® VASCULAR GRAFT WAS IMPLANTED PROXIMALLY ON THE LEFT AXILLARY ARTERY AND DISTALLY TO THE DEEP FEMORAL ARTERY. ACCORDING TO REPORTS, AN ADJUNCTIVE PROCEDURE WAS PERFORMED AND A GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED PROXIMALLY ON THE GORE-TEX® VASCULAR GRAFT AND DISTALLY TO THE LEFT SUPRA-ARTICULAR POPLITEAL ARTERY. REPORTEDLY, THE WHOLE PROCEDURE WAS UNEVENTFUL, NO ADVERSE EVENTS OR COMPLICATIONS WERE RECORDED AND THE PATENCY OF THE DEVICES WERE CONFIRMED AT THE END OF THE PROCEDURE. THE PATIENT RECEIVED AN ADDITIONAL ANTIPLATELET MEDICATION DURING THE PROCEDURE AND THE DEVICES WERE IMPLANTED AND RETAINED. ACCORDING TO REPORTS, ON (B)(6) 2014 SERIES OF ADVERSE EVENTS WERE RECORDED AND THIS INCLUDES THE FOLLOWING: "INFECTION OF THE LEFT AXILLOFEMORAL PROSTHESIS", A REINTERVENTION WAS PERFORMED AND THE DEVICES WERE EXPLANTED ON (B)(6) 2014. ANOTHER ADVERSE EVENT ALERT WAS RECORDED ON THE SAME DATE AS " SEVERE SEPSIS WITH CUTANEOUS ORIGIN, LEFT LOWER LIMB (BYPASS SCAR)" AND A REINTERVENTION WAS PERFORMED. "FLUID INFILTRATION ARO

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions; Purulent Discharge; Sepsis; Seroma

  MAUDE report 17258196 ↗
• InjuryJul 29, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT HAS BEEN REPORTED TO GORE THAT, ON (B)(6) 2016 THIS PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF PERIPHERAL ARTERIAL DISEASE LOCATED IN THE COMMON FEMORAL ARTERY AND WAS TREATED WITH A GORE-TEX VASCULAR GRAFT, THE PATIENT RECEIVED HEPARIN AS AN ADDITIONAL ANTIPLATELET TREATMENT. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE, IT WAS ALSO RECORDED THAT THE PROCEDURE WAS UNEVENTFUL, THE DEVICE WAS IMPLANTED AND RETAINED AND THAT THE PATIENT WAS DISCHARGED ON (B)(6) 2016. ON (B)(6) 2016 AN ADVERSE EVENT TERMED: LEFT INGUINAL HEMATOMA SURGERY WAS REPORTED. IT WAS RECORDED IN THE REGISTRY THAT THIS ADVERSE EVENT IS PROCEDURE-RELATED, REQUIRED AN INTERVENTION/TREATMENT AND RESOLVED WITHOUT SEQUALAE.

  Patient problems: Hematoma

  MAUDE report 15127853 ↗
• InjuryOct 2, 2020Contamination; Contamination

  IT WAS REPORTED TO GORE THAT PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN AXILLO-FEMORAL BYPASS IN ORDER TO TREAT AN ACUTE ISCHEMIA OF THE LOWER LIMB BY USING A GORE-TEX® STRETCH VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED. IT WAS STATED THAT THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2010 AND AFTER ABOUT 9 YEARS AND 2 MONTHS ON (B)(6) 2019, THE PROTHESIS WAS EXPLANTED DUE TO ITS INFECTION WHICH LASTED FOR 4 WEEKS BEFORE ITS EXPLANTATION. AS REPORTED BY THE SURGEON, NO GERM WAS FOUND.

  Patient problems: Unspecified Infection

  MAUDE report 10620041 ↗