GORE-TEX Vascular Graft V06070LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132614042), received between Sep 28, 2022 and Nov 9, 2022 — classified as 3 injuries.

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

• InjuryNov 9, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE FOLLOWING WAS REPORTED TOP GORE: ON (B)(6) 2016, THIS PATIENT REQUIRED THE CREATION OF A VASCULAR ACCESS GRAFT FOR HEMODIALYSIS SECONDARY TO A DIAGNOSIS OF END-STAGE RENAL DISEASE DURING WHICH A GORE-TEX® VASCULAR GRAFT WAS IMPLANTED. ACCORDING TO REPORTS, A LEFT-SIDE HUMERAL-AXILLARY ACCESS WAS CONFIGURED, THE PATIENT SURVIVED THE PROCEDURE, NO ADVERSE EVENT WAS EXPERIENCED DURING THE PROCEDURE AND THE DEVICE WAS SUCCESSFULLY IMPLANTED AND RETAINED. THE PATIENT WAS LATER DISCHARGED ON (B)(6) 2016. REPORTEDLY ON (B)(6) 2016, AN ADVERSE EVENT TERMED "GRAFT INFECTION WITH STAPHYLOCCOCUS AUREUS MÉTI-S" WAS IDENTIFIED. A MEDICAL INTERVENTION WAS PERFORMED. THE PRIMARY RELATIONSHIP WAS RECORDED AS DEVICE-RELATED. THE ADVERSE EVENT RESOLVED ON (B)(6) 2016.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 15757930 ↗
• InjuryNov 9, 2022Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TOP GORE: ON (B)(6) 2016, THIS PATIENT REQUIRED THE CREATION OF A VASCULAR ACCESS GRAFT FOR HEMODIALYSIS SECONDARY TO A DIAGNOSIS OF END-STAGE RENAL DISEASE DURING WHICH A GORE-TEX® VASCULAR GRAFT WAS IMPLANTED. ACCORDING TO REPORTS, A LEFT-SIDE HUMERAL-AXILLARY ACCESS WAS CONFIGURED, THE PATIENT SURVIVED THE PROCEDURE, NO ADVERSE EVENT WAS EXPERIENCED DURING THE PROCEDURE AND THE DEVICE WAS SUCCESSFULLY IMPLANTED AND RETAINED. THE PATIENT WAS LATER DISCHARGED ON (B)(6) 2016. REPORTEDLY ON (B)(6) 2016, AN ADVERSE EVENT TERMED "LEFT HAND COOLNESS" WAS IDENTIFIED. A MEDICAL INTERVENTION WAS PERFORMED. THE PRIMARY RELATIONSHIP WAS RECORDED AS DEVICE-RELATED. THE ADVERSE EVENT RESOLVED ON (B)(6) 2016. THE PATIENT RECOVERED WITH A SEQUELAE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15757884 ↗
• InjurySep 28, 2022Complete Blockage; Device Stenosis; Complete Blockage; Device Stenosis

  ON (B)(6) 2016, THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD) AND WAS TREATED FOR OCCLUSION OF THE LEFT POPLITEAL ARTERY WITH A GORE-TEX® VASCULAR GRAFT. DISTAL AND PROXIMAL ANASTOMOSES WERE BELOW KNEE. HEMATOMA EVACUATION WAS PERFORMED AFTER THE PROCEDURE. ON (B)(6) 2016, THE PATIENT PRESENTED WITH AN EDEMA ON THE LEFT LIMB, OOZING OF THE LEFT POPLITEAL SCAR, THROMBOSIS INSIDE THE GRAFT AT THE DISTAL ANASTOMOSIS, AND THROMBOSIS OF THE TIBIAL ARTERIES. THEREFORE A REINTERVENTION WAS PERFORMED. OPEN REPAIR THROMBECTOMY WAS PERFORMED, HOWEVER, PATENCY OF THE GRAFT COULD NOT BE RESTORED. THEREFORE A NEW GORE-TEX® VASCULAR GRAFT WAS IMPLANTED TO BYPASS THE LESION. IT WAS REPORTED THAT THE THROMBOSES WERE PAD RELATED. ON MARCH 5, 2016, THE PATIENT WAS DISCHARGED HOME WITH NO FURTHER EVENTS RECORDED.

  Patient problems: Peripheral Edema; Thrombosis/Thrombus

  MAUDE report 15498424 ↗