Gelweave™ 732032Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis STRAIGHT · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05037881105734), received between May 9, 2025 and May 9, 2025 — classified as 4 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).
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
- Insufficient Device Problem Information4
Patient problems
- Fever4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON 10 APR 2025. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00048 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0219.
Patient problems: Fever
MAUDE report 21991932 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON 10 APR 25. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED.
Patient problems: Fever
MAUDE report 21991926 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON 10 APR 2025. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00046 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0217.
Patient problems: Fever
MAUDE report 21991894 ↗InjuryMay 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
EVENT WAS REPORTED ON 10 APR 25. THE EVENT WAS REPORTED AFTER CLINICIAN PERFORMED A REVIEW OF PREVIOUS CASES. FOLLOWING DAY 1-2 OF IMPLANTATION, THE PATIENT WITH THE IMPLANTED DEVICE WAS REPORTED WITH A FEVER TO 101.8 OR HIGHER AND LEUCOCYTOSIS TO 20'S. NO NEGATIVE PATIENT OUTCOME OTHER THAN THE SYMPTOMS DESCRIBED WERE REPORTED.
Patient problems: Fever
MAUDE report 21991892 ↗
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.