GORE ACUSEAL Vascular Graft ECH060040ARecalls & reported problems
W. L. Gore & Associates, Inc. · GORE ACUSEAL VASCULAR GRAFT 6mmX40cm 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132605354), received between Feb 3, 2021 and Apr 12, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Peeled/Delaminated” (2 reports).
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
- Peeled/Delaminated2
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 12, 2022Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED TO GORE THAT THE GORE® ACUSEAL VASCULAR GRAFT DELAMINATED POST PROCEDURE. REPORTEDLY, DR. (B)(6) STATED THAT THE ACUSEAL DELAMINATED AND HER COULD VISUALIZE IT ON ULTRASOUND. IT WAS REPORTED THAT THE PHYSICIAN DETERMINED THE GRAFT AND ACCESS WERE COMPROMISED, SO THE PATIENT WAS TAKEN TO SURGERY AND REVISED THE GRAFT WITH ANOTHER PIECE OF ACUSEAL. REPORTEDLY THE PATIENT IS OK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14087366 ↗InjuryFeb 3, 2021Peeled/Delaminated; Peeled/Delaminated
THE FOLLOWING WAS REPORTED TO GORE: ON AN UNKNOWN DATE IN (B)(6) 2020, AN INTERPOSITION BASILIC VEIN GORE® ACUSEAL VASCULAR GRAFT WAS IMPLANTED FOR DIALYSIS. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2020, THE SURGEON PERFORMED A VENOGRAM AND OBSERVED AN IRREGULARITY IN THE GRAFT. ON (B)(6) 2021, THE PHYSICIAN ADVANCED A BARD COVERA 7MM X 40MM TO TRY TO OVERCOME THE IRREGULARITY BUT DURING THE PROCEDURE, THE IRREGULARITY MOVED FURTHER DOWN TO MAKE ANOTHER IRREGULARITY IN THE GORE® ACUSEAL VASCULAR GRAFT. THE PHYSICIAN THEN OPERATED TO ELEVATE THE GORE® ACUSEAL VASCULAR GRAFT AND NOTED THAT THE INNER LAYER HAD SEPARATED FROM THE OUTER LAYER FOR APPROXIMATELY TWO INCHES IN LENGTH. THE PHYSICIAN PROCEEDED TO EXCISE THE DELAMINATED PORTION AND IMPLANT A NEW GORE® ACUSEAL VASCULAR GRAFT TO REPLACE THE EXCISED SECTION. THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11275062 ↗
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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