Gelweave™ 73221088/10SARecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881998473), received between Sep 28, 2016 and May 8, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K090987); 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.
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2017Leak/Splash; Leak/Splash
VASCUTEK HAVE RECEIVED NOTIFICATION OF THE EVENT THAT WAS DESCRIBED AS LEAKAGE AT THE BASE OF THE BRANCH AREA. TO STOP THE LEAK, CLINICIAN PATCHED THE AFFECTED AREA WITH A FELT PIECE AND THE LEAK WAS SUCCESSFULLY STOPPED. NOTE: THE ACTUAL COMPLAINT DEVICE IS NOT APPROVED FOR SALE IN THE USA; HOWEVER, SIMILAR DEVICES ARE; THEREFORE, VASCUTEK IS REPORTING THIS EVENT.
Patient problems: No Information
MAUDE report 6551101 ↗MalfunctionSep 28, 2016Leak/Splash; Leak/Splash
THE GRAFT IN QUESTION WAS IMPLANTED AND CIRCULATION RESTARTED. AFTER A WHILE THE GRAFT STARTED TO OOZE BLOOD AT SUTURED SEGMENT BETWEEN BRANCH AND THE MAIN TRUNK. TACHO SEAL WAS APPLIED TO STOP BLEEDING.
Patient problems: No Information
MAUDE report 5982732 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K090987. 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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