Gelweave™ 73261088/10RMRecalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis SIENA COLLARED 4 BRANCH PLEXUS WITH RADIOPAQUE MARKERS · 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 05037881997780), received between Sep 11, 2026 and Sep 11, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 11, 2026Fluid/Blood Leak
Blood leakage: Blood leakage was identified at the anastomosis between the collar and the main vessel graft. There were no issues during cardiopulmonary bypass. However, after the aortic cross-clamp was released, bleeding occurred and could not be stopped. Hemostasis was achieved by using a large amount of haemostatic agents. Then, the chest was closed. Although the procedure time was extended due to the time it took to achieve hemostasis, the procedure was successfully completed.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50730737 ↗
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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