Gelweave™ 733038Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis STRAIGHT · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881106922), received between Apr 8, 2019 and Apr 10, 2019 — classified as 1 injury, 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Aneurysm2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ALLEGED DEFICIENCY DESCRIPTION: CLOTTING OCCURRED DURING A PROCEDURE FOR ASCENDING AORTIC REPLACEMENT FOR ANEURYSMAL DISEASE. WHILE CROSS CLAMP WAS STILL ON AROUND 60 MINUTES INTO THE BYPASS CLOTTING OCCURRED ON INNER AND OUTER SURFACE OF GRAFT. IT DELAYED THE PROCEDURE BY AROUND 15 MINUTES AS WHEN CLOTTING WAS NOTICED THEY HAD TO IRRIGATE THE LEFT VENTRICLE AND THE LEFT ATRIUM. PATIENT WAS FULLY HEPARINISED AND LAST ACTIVE CLOTTING FACTOR(ACT) WAS CHECKED AROUND 15 MINS PRIOR TO PROCEDURE AND WAS 500+ SECONDS. NO CLOTTING WAS NOTICED ON THE PUMP FILTER OR RESERVOIRS. GRAFT NOT PRE-SOAKED PRIOR TO USE AS RECOMMENDED BY IFU.
Patient problems: Aneurysm
MAUDE report 8501316 ↗MalfunctionApr 8, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ALLEGED DEFICIENCY DESCRIPTION: CLOTTING OCCURRED DURING A PROCEDURE FOR ASCENDING AORTIC REPLACEMENT FOR ANEURYSMAL DISEASE. WHILE CROSS CLAMP WAS STILL ON AROUND 60 MINUTES INTO THE BYPASS CLOTTING OCCURRED ON INNER AND OUTER SURFACE OF GRAFT. IT DELAYED THE PROCEDURE BY AROUND 15 MINUTES AS WHEN CLOTTING WAS NOTICED THEY HAD TO IRRIGATE THE LEFT VENTRICLE AND THE LEFT ATRIUM. PATIENT WAS FULLY HEPARINISED AND LAST ACTIVE CLOTTING FACTOR(ACT) WAS CHECKED AROUND 15MINS PRIOR TO PROCEDURE AND WAS 500+ SECONDS. NO CLOTTING WAS NOTICED ON THE PUMP FILTER OR RESERVOIRS. GRAFT NOT PRE-SOAKED PRIOR TO USE AS RECOMMENDED BY IFU.
Patient problems: Aneurysm
MAUDE report 8490475 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.