Cardioroot HEWROOT0034Recalls & reported problems
Intervascular Sas · Cardioroot Woven Collagen Coated Vascular Graft · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384401013938), received between Jun 13, 2016 and Apr 14, 2017 — classified as 1 death, 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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
- Manufacturing, Packaging or Shipping Problem1
- Material Frayed1
Patient problems
- Blood Loss1
- Death1
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 14, 2017Material Frayed; Material Frayed
THE HOSPITAL REPORTED THAT DURING A CARDIOROOT GRAFT PROCEDURE, SURGEON EXPERIENCED SOME GRAFT FRAYING AT THE POINT WHERE HE USED SCISSORS TO TRIM THE GRAFT FOR LENGTH. NO NEGATIVE PATIENT OUTCOME WAS REPORTED. THE GRAFT WAS IMPLANTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6493157 ↗DeathJun 13, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DURING A TIRON-DAVID VASCULAR SURGERY PERFORMED FOR AORTIC DISSECTION, SUTURE HOLE BLEEDING STARTED AFTER DECLAMPING THE AORTA. THE STAFF TRIED TO STOP THE BLEEDING, AND AFTER THE PATIENT WAS TRANSFERRED IN INTENSIVE CARE UNIT. IT WAS REPORTED THAT THE PATIENT DIED IN ICU DUE TO HEMORRHAGE. THE GRAFT REMAINED IMPLANTED. NO INFORMATION REGARDING THE DATES OF IMPLANTATION AND PATIENT DEATH IS AVAILABLE AT THE DATE OF THIS REPORT.
Patient problems: Blood Loss; Death; Hemorrhage/Blood Loss/Bleeding
MAUDE report 5719796 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page