Gelweave™ 730032ADPRecalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis VALSALVA · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881120140), received between Aug 9, 2018 and Aug 9, 2018 — classified as 2 injuries.
The most frequently reported specific device problem is “Obstruction of Flow” (2 reports).
1 other recall cover devices cleared under the same FDA submission (K013022, 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
- Obstruction of Flow2
Patient problems
- Cardiac Arrest2
- Infarction, Cerebral2
- Sudden Cardiac Death2
- Thrombus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2018Obstruction of Flow; Obstruction of Flow
EVENT WAS REPORTED TO VASCUTEK AS FOLLOWS: GELWEAVE VALSALVA GRAFT WAS USED FOR BENTALL PROCEDURE. EXTENSIVE THROMBOSIS OF THE VASCULAR GRAFT OCCURRED FEW HOURS AFTER SURGERY, REQUIRING SURGICAL REVASCULARIZATION. PATIENT DIED OF MASSIVE INFARCTION.
Patient problems: Cardiac Arrest; Infarction, Cerebral; Sudden Cardiac Death; Thrombus
MAUDE report 7768055 ↗InjuryAug 9, 2018Obstruction of Flow; Obstruction of Flow
EVENT WAS REPORTED TO VASCUTEK AS FOLLOWS: GELWEAVE VALSALVA GRAFT WAS USED FOR BENTALL PROCEDURE. EXTENSIVE THROMBOSIS OF THE VASCULAR GRAFT OCCURRED FEW HOURS AFTER SURGERY, REQUIRING SURGICAL REVASCULARIZATION. PATIENT DIED OF MASSIVE INFARCTION.
Patient problems: Cardiac Arrest; Infarction, Cerebral; Sudden Cardiac Death; Thrombus
MAUDE report 7768054 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K013022, 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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