Gelweave™ 732412Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis BIFURCATE · 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 05037881105857), received between Aug 27, 2024 and Aug 27, 2024 — 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
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
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.
InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EVENT REPORTED AS PART OF PANTHER STUDY (B)(4) ON (B)(6) 2024. THE EVENT WAS REPORTED AS ANEURYSM AND REPORTED AS POSSIBLY DEVICE RELATED. SUTURE ANEURYSM IN THE AREA OF THE PROXIMAL ANASTOMOSIS IN THE EVENT OF STATE: IMPLANTATION OF AN AORTOILIAC BIFURCATION PROSTHESIS ON (B)(6) 2021. REINTERVENTION REQUIRED: EVAR (UNDERSTOOD TO BE ENDOVASCULAR AORTIC REPAIR) AORTOILIAC (B)(6) 2023. PATIENT RECOVERED, RESOLVED WITHOUT SEQUELAE. THIS EVENT WAS REPORTED TO COMPLAINTS DEPARTMENT ON (B)(6) 2024, HOWEVER THE EVENT WAS NOT RAISED AT THIS TIME. AFTER REVIEW THE EVENT WAS RAISED ON (B)(6) 2024. AN INTERNAL NON-CONFORMANCE HAS BEEN RAISED TO INVESTIGATE THIS LATE REPORTING AND PROVIDE PREVENTATIVE ACTIONS IF REQUIRED. THIS EVENT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MFG REPORT NUMBER 9612515-2024-00061 TO PROVIDE EVENT CLOSURE INFORMATION FOR (B)(4).
Patient problems: Aneurysm
MAUDE report 20075761 ↗
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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