Gelweave™ 732038Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis STRAIGHT · Class 2 · Implant
All models of Gelweave (47)
Data updated Oct 16, 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 05037881105048), received between May 13, 2026 and May 13, 2026 — 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- No Apparent Adverse Event1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2026No Apparent Adverse Event; Insufficient Device Problem Information
INCIDENT WAS RECEIVED FROM THE PATIENT'S LEGAL REPRESENTATIVE AND A SUMMARY OF THE INCIDENT INFORMATION IS STATED BELOW: ON THE EVENING OF (B)(6) 2024, A FEW HOURS AFTER THE INTERVENTION DESCRIBED AS "REPLACEMENT OF THE ASCENDING AORTA WITH A DACRON PROSTHESIS OF 38 MM DIAMETER WITH REINFORCEMENT OF PROXIMAL AND DISTAL ANASTOMOSES USING ACUSEAL STRIPS AND BIO GLUE SURGICAL ADHESIVE UNDER EXTRACORPOREAL CIRCULATION (ECC)," MY WIFE BEGAN RECEIVING AUTOMATIC SMS MESSAGES STATING, "MRI STROKE." AS NO ONE HAD INFORMED HER THAT I WAS IN A SERIOUS, UNCONSCIOUS CONDITION, SHE CALLED THE HOSPITAL, WHERE ICU STAFF INFORMED HER THAT, I HAD SUFFERED 7 STROKES."CONSIDERING THE CARDIO-EMBOLIC NATURE OF THE EVENTS, THE NUMBER OF 7 STROKES, AND THE CONTEXT OF SURGERY INVOLVING IMPLANTATION OF PROSTHETIC MATERIALS AND USE OF SURGICAL ADHESIVES, THERE IS A HIGH MEDICAL PROBABILITY THAT THE EMBOLIC SOURCE WAS THE FORMATION OF A THROMBUS DIRECTLY RELATED TO THE IMPLANTED MEDICAL DEVICES OR THEIR MATERIAL. AS A RESULT OF THE INCIDENT THE PATIENT IS REPORTING AN "INABILITY TO WORK AND PERMANENT BLINDNESS". THIS EVENT OCCURED WHEN THE PATIENT WAS HOSPITALISED IN (B)(6).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Stroke/CVA
MAUDE report 25158761 ↗
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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