Intergard IGW0020-30Recalls & reported problems
Intervascular Sas · Intergard Woven Straight Collagen Coated Vascular Graft · Class 2 · Implant
- 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 00384401000167), received between Oct 12, 2015 and Jan 3, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Component Missing” (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
- Component Missing1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Blood Loss1
- 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.
MalfunctionJan 3, 2025Component Missing; Component Missing
IT HAS BEEN REPORTED TO INTERVASCULAR THAT THE INTERGARD WOVEN GRAFT BOX (I.E. SECONDARY PACKAGING) WAS FOUND TO BE EMPTY WHEN THE NURSING TEAM CHECKED IT DURING THE PROCEDURE. THE PATIENT SET AND IFU WERE PRESENT IN THE BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21065485 ↗InjuryOct 12, 2015Manufacturing, Packaging or Shipping Problem
AFTER CLARIFICATION RECEIVED ON OCTOBER 21, 2015, THE DEVICE WAS REPORTED BY ERROR. NO PRODUCT PROBLEM NOR ADVERSE EVENT IS ASSOCIATED WITH THE PRODUCT.
Patient problems: Blood Loss
MAUDE report 5144176 ↗
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.