Cardioroot HEWROOT0032Recalls & 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
- 10
- Deaths reported
- 2
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00384401013921), received between Feb 5, 2021 and Jul 16, 2025 — classified as 2 deaths, 6 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Flaked” (3 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.
Reports received per month
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
- Flaked3
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information2
- Material Frayed2
- Patient Device Interaction Problem2
- Use of Device Problem2
- Delivered as Unsterile Product1
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Hemorrhage/Blood Loss/Bleeding2
- High White Blood Cell Count2
- Hypersensitivity/Allergic reaction2
- No Patient Involvement1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryJul 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED TO INTERVASCULAR THAT, ON (B)(6) 2024 A PATIENT WAS TREATED IN THE OPERATING ROOM FOLLOWING AN ASCENDING AORTIC ANEURYSM. DURING THIS PROCEDURE, THE FOLLOWING DEVICES WERE USED: BIOGLUE 10ML SYRINGE (REFERENCE: (B)(4); SUPPLIER: (B)(4), CARDIOROOT AORTIC VASCULAR PROSTHESIS WITH BULB D32MM L15CM (HEWROOT0032) (REFERENCE: (B)(4); SUPPLIER: (B)(4), AVALUS BOVINE AORTIC VALVE D27MM (REFERENCE: (B)(4); SUPPLIER: (B)(4). SINCE THIS PROCEDURE, THE PATIENT HAS SUFFERED FROM CHRONIC HYPEREOSINOPHILIA. AN ETIOLOGICAL ASSESSMENT WAS PERFORMED BY THE HOSPITAL AND NO CAUSE WAS FOUND. THE PARASITOLOGICAL EXAMINATION WAS NEGATIVE AND THE DRUG-RELATED CAUSE RULED OUT WITH PHARMACOVIGILANCE.
Patient problems: High White Blood Cell Count; Hypersensitivity/Allergic reaction
MAUDE report 22519742 ↗InjuryJul 11, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED TO INTERVASCULAR THAT, ON (B)(6) 2024, A PATIENT WAS TREATED IN THE OPERATING ROOM FOLLOWING AN ASCENDING AORTIC ANEURYSM. DURING THIS PROCEDURE, THE FOLLOWING DEVICES WERE USED: - BIOGLUE 10ML SYRINGE (REFERENCE: (B)(4); SUPPLIER: (B)(4)), - CARDIOROOT AORTIC VASCULAR PROSTHESIS WITH BULB D32MM L15CM (HEWROOT0032) (REFERENCE: (B)(4); SUPPLIER: (B)(4)). - AVALUS BOVINE AORTIC VALVE D27MM (REFERENCE: (B)(4); SUPPLIER: (B)(4)). SINCE THIS PROCEDURE, THE PATIENT HAS SUFFERED FROM CHRONIC HYPEREOSINOPHILIA. AN ETIOLOGICAL ASSESSMENT WAS PERFORMED BY THE HOSPITAL AND NO CAUSE WAS FOUND. THE PARASITOLOGICAL EXAMINATION WAS NEGATIVE AND THE DRUG-RELATED CAUSE RULED OUT WITH PHARMACOVIGILANCE.
Patient problems: High White Blood Cell Count; Hypersensitivity/Allergic reaction
MAUDE report 22480110 ↗DeathMar 28, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
DeathMar 27, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
InjurySep 12, 2023Material Frayed; Use of Device Problem; Material Frayed; Use of Device Problem
COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17728410 ↗InjurySep 8, 2023Material Frayed; Use of Device Problem; Material Frayed; Use of Device Problem
COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17711848 ↗MalfunctionMar 31, 2022Flaked; Flaked
IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE CARDIOROOT WOVEN GRAFT WAS REMOVED FROM THE PACKAGE ON THE OPERATING TABLE, IT SHOWED A LESION OF THE INTERNAL COLLAGEN LINING THAT FLAKED OFF INTO FRAGMENTS WITH THE ONLY MANIPULATION. THE PROSTHESIS WAS THEREFORE NOT IMPLANTED ON THE PATIENT AND A SIMILAR ONE WAS USED, WHICH DID NOT PRESENT THE SAME PROBLEM. THE SURGERY WAS NOT DELAYED, THEY TOOK ANOTHER CARDIOROOT AND WENT ON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13964318 ↗InjuryAug 17, 2021Flaked; Flaked
SEE INITIAL MFG REPORT # : 1640201-2021-00027 (COMPLAINT #(B)(4). ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 10, 2021 REGARDING THE EVENT: "SMALL PIECES OF THE GRAFT WAS COMING OFF ON THE SURGEON'S HAND." "THE SURGERY WAS DELAYED SHORTLY WHILE THEY GRAB ANOTHER GRAFT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12334103 ↗InjuryAug 12, 2021Flaked; Flaked
SEE INITIAL MFG REPORT # : 1640201-2021-00027 (COMPLAINT #(B)(4)). ADDITIONAL INFORMATION WAS RECEIVED ON SEPTEMBER 10, 2021 REGARDING THE EVENT: "SMALL PIECES OF THE GRAFT WAS COMING OFF ON THE SURGEON'S HAND." "THE SURGERY WAS DELAYED SHORTLY WHILE THEY GRAB ANOTHER GRAFT".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12312203 ↗MalfunctionFeb 5, 2021Delivered as Unsterile Product; Device Damaged Prior to Receipt by User; Delivered as Unsterile Product; Device Damaged Prior to Receipt by User
SEE INITIAL MFR REPORT 1640201-2021-00004, COMPLAINT # (B)(4).
Patient problems: No Patient Involvement
MAUDE report 11284815 ↗
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
- 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
- ADVANTA SLIDER GDS 22187Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall6 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.