Gelweave™ 735028/8SRecalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis LONGER ANTE-FLO OFFSET BRANCH · Class 2 · Implant
All models of Gelweave (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881106731), received between Jan 5, 2021 and Jul 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (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.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 15, 2026
WE OPENED THE GELWEAVE GELATIN WOVEN VASCULAR PROSTHESIS. PER DR. [REDACTED] IT WAS FALLING APART; SHE DECIDED TO NOT USE THE GRAFT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25825120 ↗MalfunctionApr 7, 2022Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2020 GELWEAVE ANTE-FLO GRAFT IMPLANTED, LEAKAGE WAS NOTED DURING OPERATION WHEN CLAMPS WERE REMOVED, CONSTANT BLEEDING WAS NOTED FROM LONG ANTE-FLO BRANCH. GRAFT WAS PRE-SOAKED AS ADVISED IN THE IFU. SUTURES WERE APPLIED TO STOP THE LEAK. PROCEDURE WAS EXTENDED BY ABOUT 5 MINUTES. PATIENT RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14039486 ↗MalfunctionJan 5, 2021Material Puncture/Hole; Material Integrity Problem; Material Puncture/Hole; Material Integrity Problem
A GELWEAVE ANTEFLO DEVICE WAS REPORTED TO HAVE LEAKED AT THE BRANCH/BODY INTERFACE (BRANCH ROOT). THE LEAKING SITE WAS SUTURED USING PROLENE AND THE LEAK STOPPED. SMALL BLOOD LOSS WAS REPORTED, AND 2 MINUTES EXTRA SURGERY TIME WAS REQUIRED TO SEW THE LEAKING AREA. NO PATIENT HARM OR INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11116331 ↗
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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