Cardioroot HEWROOT0026Recalls & reported problems
Intervascular Sas · Cardioroot Woven Collagen Coated Vascular Graft · Class 2 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00384401013891), received between Jun 7, 2017 and Feb 7, 2023 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Aug 12, 2026Open, Classified
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
Z-3258-2026 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Nonstandard Device2
- Flaked1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding2
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryFeb 7, 2023Nonstandard Device; Nonstandard Device
InjuryJan 27, 2023Nonstandard Device; Nonstandard Device
MalfunctionApr 20, 2018Flaked; Flaked
THE HOSPITAL REPORTED THAT THE SEALING COLLAGEN COAT OF THE VASCULAR GRAFT DETACHED SPONTANEOUSLY FROM THE INNER SURFACE.
Patient problems: No Patient Involvement
MAUDE report 7446496 ↗MalfunctionJun 7, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
THE HOSPITAL REPORTED THAT DURING AN ASCENDING AORTA DISSECTION PROCEDURE, A CARDIOROOT GRAFT WAS BEING IMPLANTED AND HAD TO BE REMOVED BECAUSE OF A YELLOW SUBSTANCE ON THE INTERIOR PART OF THE GRAFT. NO PATIENT EFFECT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6618110 ↗
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.