Gelweave™ 732012/8X2Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis TRIFURCATE ARCH GRAFT · Class 2 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05037881998077), received between Aug 6, 2020 and Aug 6, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Material Integrity Problem1
- Material Perforation1
- Material Puncture/Hole1
Patient problems
- Aneurysm1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 6, 2020Material Puncture/Hole; Material Perforation; Material Integrity Problem; Material Puncture/Hole; Material Perforation; Material Integrity Problem
BLOOD LEAKAGE (BRANCH): THE PATIENT HAD AAA. AFTER AAA WAS TREATED, THE GELWEAVE TRIFURCATE WAS USED FOR THORACOABDOMINAL AORTA DEBRANCHING. A GUIDE SHEATH FOR A STENT GRAFT (24 FR DRYSEAL SHEATH) WAS INSERTED INTO THE 12-MM GRAFT BODY OF THE GELWEAVE TRIFURCATE AND THE OTHER END WAS ANASTOMOSED WITH THE CELIAC ARTERY. THE UPPER 8-MM SIDE BRANCH WAS ANASTOMOSED WITH THE RIGHT RENAL ARTERY, AND THE LOWER SIDE BRANCH WAS ANASTOMOSED WITH THE SIDE OF THE SMA. THE ANASTOMOSIS ON THE HEEL PART OF THE BRANCH BODY WHERE THE LOWER SIDE BRANCH WAS ANASTOMOSED WITH THE SIDE OF THE SMA WAS INSUFFICIENT, RESULTING IN BLOOD LEAKAGE. THE HEEL PART WAS SUTURED WITH A FEW STITCHES TO ACHIEVE HEMOSTASIS. SINCE HEMOSTASIS WAS SUCCESSFULLY ACHIEVED, THE GELWEAVE TRIFURCATE WAS IMPLANTED WITHOUT REPLACEMENT. SUBSEQUENTLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY HEALTH DAMAGE. OPERATION TYPE: THORACOABDOMINAL AORTA DEBRANCHING ASSOCIATED WITH ENDOVASCULAR AORTIC REPAIR.
Patient problems: Aneurysm
MAUDE report 10372345 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.