Gelweave™ 731407XL55Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis EXTRA LONG BIFURCATE · Class 2 · Implant
All models of Gelweave (47)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881107622), received between Apr 23, 2020 and Apr 23, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Infusion or Flow Problem” (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.
Most reported problems
Device problems
- Infusion or Flow Problem1
Patient problems
- Thrombosis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 23, 2020Infusion or Flow Problem; Infusion or Flow Problem
FURTHER INFORMATION RECEIVED 27-APR-20: A 60-YEAR-OLD MAN HOSPITALISED IN OUR SERVICE FOR PERIPHERAL ARTERY DISEASE, RUTHERFORD 4 ON THE LEFT LOWER LIMB AND 3 ON THE RIGHT SIDE. PAST MEDICAL HISTORY: PROSTHETIC FEMORAL-FEMORAL CROSS-BYPASS (DATE UNKNOWN), REPLACED BY A NEW FEM-FEM BYPASS (DATE UNKNOWN), EVENTUALLY REPLACED BY A CRYOPRESERVED VEINOUS GRAFT. THE PATIENT KEPT SYMPTOMATIC, SO WE DECIDED TO REVASCULARIZE WITH AN AORTO- BI-FEMORAL BYPASS. CARDIO-VASCULAR RISK FACTORS: HBP, DYSLIPIDEMIA, NO DIABETES, NO ACTIVE SMOKING. DURING THE PROCEDURE, THREE EPISODES OF ACUTE THROMBOSIS OCCURRED WITHOUT ANY TRIGGER. MULTIPLE THROMBECTOMIES WERE NEEDED TO RESTORE BLOOD FLOW, FOLLOWED BY CONTINUOUS INTRAVENOUS HEPARIN PERFUSION, CHECKED BY REGULAR HEPARINEMIA RATES BETWEEN 0.2 AND 0.4. THE DAY AFTER THE SURGERY, HE PRESENTED WITH AN ACUTE ISCHEMIA TO THE RIGHT LOWER LIMB, ONCE AGAIN WITHOUT TRIGGER, TREATED SUCCESSFULLY WITH FOGARTY THROMBECTOMY. THE THROMBOPHILIA TEST WAS NORMAL. A CHEST AND ABDOMINAL CT-SCAN FAILED TO UNCOVER ANY OTHER DISEASE. EVENTUALLY, THE PATIENT, AFTER BEING DISCHARGED AT DAY-10, CAME BACK AT DAY-27 WITH FALSE ANEURYSM TO THE RIGHT GROIN, OBVIOUSLY SEPTIC, WITH
Patient problems: Thrombosis
MAUDE report 9989514 ↗
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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