Gelweave™ 73241088/10RMRecalls & 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 05037881997797), received between Jan 29, 2025 and Jan 29, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Ischemic Heart Disease1
- Pseudoaneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EVENT DATE: (B)(6) 2024 IMPLANT DATE (B)(6) 2020 EXPLANT DATE: (B)(6) 2024 FAILURE OF BYPASS ANASTOMOSES: ON (B)(6) 2020, THE PATIENT UNDERWENT TAR AND CAPG FOR TREATMENT OF THORACIC AORTIC ANEURYSM AND ISCHEMIC HEART DISEASE. THE TWO CORONARY ARTERIES WERE BYPASSED TO THE PROXIMAL PORTION OF THE GELWEAVE GRAFT USING SAPHENOUS VEIN GRAFTS (SGV). ON (B)(6) 2024, AN INTERVENTION WAS PERFORMED DUE TO SUSPECTED PSEUDOANEURYSM. THE CHEST WAS OPENED VIA A MIDLINE INCISION. EXAMINATION OF THE TREATMENT SITE REVEALED FAILURE OF THE ANASTOMOSES OF THE TWO BYPASSES BETWEEN THE SVG AND THE PROXIMAL PORTION OF THE VASCULAR PROSTHESIS, WHICH HAD BEEN ANASTOMOSED IN THE PREVIOUS SURGERY FOR ISCHEMIC HEART DISEASE. THE VASCULAR PROSTHESIS WAS REMOVED FROM THE PATIENT. CABG AND ASCENDING AORTIC REPLACEMENT WERE PERFORMED. EXAMINATION OF THE ANASTOMOSES OF THE REMOVED VASCULAR PROSTHESIS REVEALED THAT THE SUTURES REMAINED THROUGHOUT THE ANASTOMOSES, AND IT WAS UNCLEAR WHY THE ANASTOMOSES WERE SEPARATED. THE PATIENT CONDITION IS STABLE.
Patient problems: Ischemic Heart Disease; Pseudoaneurysm
MAUDE report 21263712 ↗
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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