Gelweave™ 731809XL55Recalls & 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 05037881107646), received between May 6, 2022 and May 6, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (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
- Obstruction of Flow1
Patient problems
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 6, 2022Obstruction of Flow; Obstruction of Flow
THIS EVENT WAS REPORTED TO VASCUTEK VIA THE PANTHER STUDY PROGRAMME AS FOLLOWS: REPORTED RIGHT LEG THROMBOSIS WITH THROMBUS WITHIN THE RIGHT DEEP FEMORAL ARTERY, LEFT DEEP FEMORAL ARTERY AND THE LEFT HYPOGASTRIC ARTERY. THE GRAFT WAS IMPLANTED ON (B)(6) 2019. THE PATIENT HAD A HAEMORRHAGIC SHOCK EVENT SEVERAL HOURS AFTER THE BYPASS PROCEDURE AE FIRST DETECTED ON (B)(6) 2019 THROMBECTOMY WAS PERFORMED ON (B)(6) 2019, AE RESOLVED ON (B)(6) 2019. THIS EVENT WAS INDICATED AS DEVICE RELATED, NOT PROCEDURE RELATED, PATIENT PRE-EXISTING CONDITION UNKNOWN). NO DEVICE DEFECT OR DEFICIENCY WAS REPORTED BY THE SITE.
Patient problems: Thrombosis/Thrombus
MAUDE report 14304356 ↗
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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