Gelweave™ 733008Recalls & reported problems
Vascutek Ltd · Gelweave Gelatin Impregnated Woven Vascular Prosthesis STRAIGHT · Class 2 · Implant
- Adverse event reports
- 7
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05037881105130), received between Nov 26, 2020 and May 28, 2025 — classified as 1 death, 1 injury, 5 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (3 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
- Material Integrity Problem3
- Contamination /Decontamination Problem1
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
- Labelling, Instructions for Use or Training Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information2
- Post Operative Wound Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2025Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem
GELWEAVE STRAIGHT RECEIVED BY CUSTOMER WITH LABELS MISSING FROM INSIDE CARTON.( ONLY ONE WAS IN THERE RATHER THAN THE NORMAL X 4 STICKERS) GRAFT WAS IMPLANTED WITH NO ISSUES, THE ONE LABEL PRESENT WAS USED. HOSPITALS USE THE SPARE STICKERS PROVIDED ON DOCUMENTATION AS NEEDED, BUT IN THIS CASE, THEY ONLY HAD ONE. THIS REPORT IS BEING SUBMITTED AS FOLLOW UP #1 FOR MANUFACTURING REPORT NUMBER 9612515-2025-00055 TO PROVIDE EVENT CLOSURE INFORMATION FOR TAG0249.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22094860 ↗DeathFeb 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
GRAFT WAS LEAKING BLOOD DURING PROCEDURE. PHYSICIAN STATED IT WAS NOT HANDLING BLOOD THE WAY IT NORMALLY WOULD.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18693353 ↗InjuryAug 4, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem
THIS EVENT WAS REPORTED VIA THE PANTHER STUDY PROGRAMME AS FOLLOWS: A GELWEAVE STRAIGHT GRAFT WAS UTILISED AS PART OF AN ECMO PROCEDURE (ECMO CANNULATION) ON (B)(6) 2020. ON (B)(6) 2020 A FESTERING WOUND INFECTION WAS REPORTED . ON (B)(6) 2020 THE GELWEAVE GRAFT WAS EXPLANTED.. THE EVENT WAS INDICATED AS DEVICE, PATIENT AND PROCEDURE RELATED.
Patient problems: Post Operative Wound Infection
MAUDE report 15162582 ↗MalfunctionJun 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
EVENT WAS REPORTED AS FOLLOWS: GRAFT SOAKED IN NORMAL SALINE FOR 3 MINS PRIOR TO REMOVAL AND USED FOR FEMORAL ARTERY ANASTOMOSIS FOR CARDIOPULMONARY BYPASS CANNULATION. BLOOD CONSTANTLY LEAKING THROUGH PERMEABLE GELWEAVE GRAFT. THE PATIENT WAS PROFUSELY BLEEDING OUT OF THE FEMORAL ARTERY FOR THE DURATION OF THE CASE. THE RESULT WAS HAEMOLYSIS, CONSTANT BLOOD LOSS AND INTERRUPTION TO THE SURGICAL PROCEDURE. PATIENT WAS UNDERGOING CORONARY BYPASS AND AORTIC VALVE REPLACEMENT. ESTIMATED BLOOD LOSS >250ML.
Patient problems: Insufficient Information
MAUDE report 14673661 ↗MalfunctionAug 13, 2021Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2021 THE FACILITY THAT WAS USING THE GELWEAVE GRAFT REPORTED THAT IT WAS LEAKING (POROUS). THE EXCESS BLOOD WAS SUCTIONED AWAY AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12317323 ↗MalfunctionMar 1, 2021Material Integrity Problem; Material Integrity Problem
ON (B)(6) 2021, THE SURGEON UTILISED A GELWEAVE STRAIGHT GRAFT FOR AXILLARY CANNULATION INTO A PATIENT. APPROXIMATELY 90MINS INTO THE PROCEDURE THE GELWEAVE BRANDED GRAFT STARTED TO LEAK (BLOOD WAS LEAKING ON TO THE FLOOR). THE GRAFT WAS WIPED, BUT IT CONTINUED TO LEAK. THE GRAFT WAS UNDER PRESSURE (AT AN UNKNOWN LEVEL) AND THE PATIENTS TEMPERATURE WAS AT 34 DEGREES. NO INTERVENTION WAS PERFORMED BY THE CLINICAL TEAM DURING USE AND NO NEGATIVE EFFECT HAS BEEN REPORTED WITH REGARDS TO THE PATIENTS CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11392043 ↗MalfunctionNov 26, 2020Material Integrity Problem; Material Integrity Problem
REPORTED TO VASCUTEK LTD. AS FOLLOWS: PATIENT WAS BEING PLACED ON ECMO, AND PRODUCT WAS USED TO GAIN ARTERIAL ACCESS FOR BYPASS. ONCE THE PATIENT WAS PLACED ON BYPASS IT WAS NOTED THAT THERE WAS SIGNIFICANT BLOOD LEAKAGE THROUGH THE GRAFT FABRIC. SURGEON INSPECTED THE GRAFT SUTURE LINE TO DETERMINE WHETHER IT WAS LOCATED THERE, BUT DETERMINED THE LEAKAGE WAS OCCURRING THROUGH THE ENTIRE GRAFT MATERIAL. SURGEON HAD TO INSERT A CANNULA INTO THE GRAFT TO MINIMISE THE BLOOD LOSS FROM THE ARTERY. PATIENT LOST APPROXIMATELY 5L OF BLOOD DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10910331 ↗
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.