Gelweave™ 73261088/8Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis 4 BRANCH PLEXUS · Class 2 · Implant
All models of Gelweave (47)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05037881106335), received between Aug 15, 2017 and Jan 14, 2026 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K090987, K162794); they may or may not involve this specific model.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Integrity Problem2
- Fluid/Blood Leak1
- Material Perforation1
- Material Puncture/Hole1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
DeathJan 14, 2026Fluid/Blood Leak
DURING AORTIC SURGERY WITH VASCUTEK GELWEAVE 4 BRANCH PLEXUS 26 MM THERE WAS BLEEDING AROUND THE GRAFT. PATIENT OUTCOME IS UNKNOWN AT THIS TIME
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 24066640 ↗MalfunctionMay 2, 2019Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem
EVENT WAS REPORTED TO VASCUTEK LTD AS FOLLOWS: "OOZING BLOOD FROM NEEDLE HOLE". ACCOMPANYING VIDEO SHOWS LEAKAGE FROM SEWN AREA OF BRANCH ROOT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8572596 ↗MalfunctionAug 15, 2017Material Integrity Problem; Material Integrity Problem
DURING THE IMPLANT PROCEDURE, BLOOD WAS OOZING / SEEPING FROM A BRANCH ROOT. THE DISTRIBUTOR ADVISED THAT THE LEAKING GRAFT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN GRAFT. THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES.
Patient problems: No Information
MAUDE report 6793636 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K090987, K162794. One submission often covers many models, so check the product and lot details in each record.
- Z-2542-2021 · Jul 8, 2021 · TerminatedThe Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave Trifurcate, Gelweave Ant-Flo, and Gelweave Val
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
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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