GORE ACUSEAL Vascular Graft ECH460045ARecalls & reported problems
W. L. Gore & Associates, Inc. · GORE ACUSEAL VASCULAR GRAFT 4-6mmX45cm Tapered Heparin · Class 2 · Implant
All models of GORE ACUSEAL Vascular Graft (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132634811), received between Jan 22, 2020 and Jan 22, 2020 — classified as 1 injury.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Aug 26, 2025Class IIOpen, Classified
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to reintervention procedures, so Instructions for Use will be updated to modify existing warning to 1) further clarify techniques that may contribute to the risk of delamination, 2) Addition of delamination to device-related adverse event section.
Z-0036-2026 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Blood Loss1
- Fistula1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT RECEIVED A FISTULA FOR AV ACCESS AT THE UNIVERSITY HOSPITAL OF (B)(6) AND IS SENT HOME TO (B)(6) FOR DIALYSIS AT FRESENIUS KIDNEY CARE. AFTER APPROXIMATELY 2 WEEKS OF DIALYSIS WITH THE FISTULA, THE PATIENT RETURNS TO UNIVERSITY HOSPITAL OF (B)(6), AS THE FISTULA HAS BECOME NON-FUNCTIONAL (UNABLE TO BE USED FOR DIALYSIS). THE FISTULA IS ABANDONED AND THE SURGEON WHO CREATED THE FISTULA, IMPLANTS A GORE® ACUSEAL VASCULAR GRAFT ON (B)(6) 2020 IN THE UPPER ARM. THE PATIENT RETURNS TO HAZARD, KENTUCKY FOR DIALYSIS. PATIENT PRESENTED AT FRESENIUS KIDNEY CARE ((B)(6)) FOR DIALYSIS (B)(6) 2020 (2 DAYS POST IMPLANT). TWO 17 GAUGE DIALYSIS NEEDLES ARE USED TO ACCESS INFLOW AND OUTFLOW OF THE ACUSEAL GRAFT AND THE DIALYSIS MACHINE IS ADJUSTED TO 100ML PER MINUTE FOR THE INITIAL TIME PERIOD ON DIALYSIS. DURING THE DIALYSIS SESSION THE PATIENT COMPLAINED ABOUT ARM PAIN AND SWELLING/HEMATOMA WAS OBSERVED. THE PATIENT WAS SENT TO (B)(6) MEDICAL CENTER ER WITH THE TWO DIALYSIS NEEDLES STILL IN THE ARM. FASCIOTOMY IS PERFORMED TO CONTROL BLEEDING AND TO TREAT COMPARTMENT SYNDROME. THE ER SURGEON REPORTED THERE WERE NO VISIBLE PROBLEMS ASSOCIATED WITH
Patient problems: Blood Loss; Fistula
MAUDE report 9618623 ↗
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 · each recall links to the FDA recall notice
- 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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