Gelweave™ 733028Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis STRAIGHT · Class 2 · Implant
Data updated Oct 13, 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 05037881106885), received between Jan 13, 2025 and Jan 13, 2025 — 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- Abscess1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EVENT DATE: 15 OCT 24 IMPLANT DATE: ON (B)(6) 2021. EVENT REPORTED FORM PANTHER STUDY) (6) SUBJECT (B)(6), A 43-YEAR-OLD, WHITE, MALE WITH AN ASCENDING AORTA ANEURYSM, EXPERIENCED A SERIOUS ADVERSE EVENT OF ABSCESS. THE SUBJECT UNDERWENT AN OPEN SURGICAL REPAIR WITH A GELWEAVE STRAIGHT DEVICE ON (B)(6) 2021. ON POST OPERATIVE DAY 1072 (B)(6)2024), THE SUBJECT EXPERIENCED THE SERIOUS ADVERSE EVENT OF ABSCESS. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A FEVER OF 103.1F. PATIENT STATED THIS IS THE SAME WAY HE FELT THE LAST TIME HE HAD ENDOCARDITIS THAT LED TO INITIAL GELWEAVE PROCEDURE. PATIENT WAS DISCHARGED BUT LATER BROUGHT BACK TO THE EMERGENCY DEPARTMENT AFTER HE CONTINUED TO HAVE FEVERS THAT WORSENED WITH OTHER SYMPTOMS. IMAGING ON (B)(6) 2024, REVEALED A PARAVALVULAR LEAK AND STARTED ON ANTIBIOTICS FOR SUSPECTED ENDOCARDITIS. PLANNED RE-DO PROCEDURE ON (B)(6) 2024 WHERE AN ABSCESS WAS FOUND AND CULTURES TAKEN THAT CAME BACK POSITIVE. GELWEAVE DEVICE WAS EXPLANTED DURING RE-DO PROCEDURE ON (B)(6) 2024. THE SUBJECT WAS DISCHARGED ON (B)(6) 2024. AS THE DEVICE WAS EXPLANTED, THE SUBJECT WILL NO LONGER BE FOLLOWED UP IN THE STUDY. THE INVESTIGATOR CONSIDERED THE EVENT
Patient problems: Abscess
MAUDE report 21136388 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page