GORE ACUSEAL Vascular Graft ECH470045ARecalls & reported problems
W. L. Gore & Associates, Inc. · GORE ACUSEAL VASCULAR GRAFT 4-7mmX45cm Tapered Heparin · Class 2 · Implant
All models of GORE ACUSEAL Vascular Graft (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132626984), received between Feb 8, 2022 and Aug 11, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Complete Blockage” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Complete Blockage1
- Peeled/Delaminated1
Patient problems
- Hematoma1
- Insufficient Information1
- Thrombosis/Thrombus1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A DIALYSIS PATIENT WAS IMPLANTED WITH A GORE® ACUSEAL VASCULAR GRAFT (ACUSEAL VG) FOR DIALYSIS ACCESS IN THE RIGHT FOREARM. ON (B)(6) 2025, THE PATIENT PRESENTED WITH A LARGE HEMATOMA AT THE IMPLANT LOCATION. THE EDEMA INVOLVING THE EPIDERMIS WAS DRAINED. AS REPORTED, THE ACUSEAL VG HAD NOT BEEN CANNULATED. THE PHYSICIAN STATED THE PATIENT APPEARS TO HAVE DEVELOPED AN ALLERGIC REACTION. THE PATIENT DOES NOT HAVE HIT TYPE 2 OR ANY KNOWN ALLERGIES. AN UPDATE WAS PROVIDED ON (B)(6) 2025. IT WAS REPORTED THE CONDITION OF THE PATIENT'S ARM HAS GREATLY IMPROVED, WITH SOME REMAINING EDEMA. THERE ARE NO PLANS FOR ADDITIONAL INTERVENTION OR GRAFT EXPLANT.
Patient problems: Hematoma
MAUDE report 22772139 ↗InjuryMar 12, 2025Complete Blockage; Complete Blockage
THE FOLLOWING WAS REPORTED TO GORE: A PATIENT PRESENTED FOR AN ARTERIOVENOUS (A-V) ACCESS REVISION IN THE LEFT UPPER ARM. AS REPORTED, AN A-V GRAFT LOOP (GORE® ACUSEAL VASCULAR GRAFT) WAS IMPLANTED ON (B)(6) 2025. NOW THE LOOP GRAFT HAD CLOTTED AND REQUIRED AN OPEN THROMBECTOMY. FISTULAGRAM ON BOTH ARTERIAL AND VENOUS ANASTOMOSIS REVEALED SIGNIFICANT STENOSIS TO THE VENOUS OUTFLOW THAT REQUIRED STENTING. ON (B)(6) 2025, AN 8FR X 10CM BRITE TIP SHEATH WAS USED TO ADVANCE THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) TO THE INTENDED TREATMENT SITE. THE VIABAHN DEVICE WAS PLACED AND DEPLOYED FINE. AS THE DELIVERY CATHETER WAS WITHDRAWN, THE DISTAL TIP CAUGHT ON THE EDGE OF THE SHEATH. IT WAS REPORTED THE DISTAL TIP CAME OFF. THE PHYSICIAN WAS ABLE TO RETRIEVE THE DISTAL TIP ALONG WITH THE SHEATH REMOVAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: Thrombosis/Thrombus
MAUDE report 21589085 ↗InjuryFeb 8, 2022Peeled/Delaminated; Peeled/Delaminated
THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE, A PATIENT UNDERWENT REVISION OF AN AV FISTULA INVOLVING A GORE® ACUSEAL VASCULAR GRAFT THAT HAD BEEN IMPLANTED IN (B)(6) 2019. IT WAS REPORTED THAT THERE WAS POSSIBLE DELAMINATION. MORE INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 13479724 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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