Gelweave™ 733010Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05037881105147), received between Jan 6, 2021 and Nov 4, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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.
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Fluid/Blood Leak1
- Inaccurate Information1
- Labelling, Instructions for Use or Training Problem1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2022Fluid/Blood Leak; Fluid/Blood Leak
DURING PROCEDURE ON (B)(6) 2022, 10MM GELWEAVE GRAFT THAT WAS USED FOR AXILLIARY CANNULATION WAS LEAKING.
Patient problems: Insufficient Information
MAUDE report 15734278 ↗MalfunctionJan 6, 2021Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information; Labelling, Instructions for Use or Training Problem; Device Markings/Labelling Problem; Inaccurate Information
EVENT WAS REPORTED TO VASCUTEK LTD. ON (B)(6) 2020: THE PACKAGE INDICATED A GELWEAVE STRAIGHT TUBE GRAFT 733010. AFTER OPENING THE BOX AND FOIL POUCH IT TURNED OUT THAT INSTEAD OF THE TUBE GRAFT THERE WAS A GELWEAVE VALSALVA INSIDE THE INNER BLISTER. THE CUSTOMER OPENED ANOTHER BOX INSTEAD. NO CONSEQUENCES FOR THE PATIENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11122389 ↗
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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