Cardioroot HEWROOT0030Recalls & reported problems
Intervascular Sas · Cardioroot Woven Collagen Coated Vascular Graft · Class 2 · Implant
All models of Cardioroot (6)
Data updated Oct 16, 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
- 13
- Deaths reported
- 2
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00384401013914), received between Mar 24, 2017 and Apr 13, 2026 — classified as 2 deaths, 5 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Flaked” (4 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 16, 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Flaked4
- Insufficient Device Problem Information4
- Adverse Event Without Identified Device or Use Problem2
- Delivered as Unsterile Product1
- Device Damaged Prior to Receipt by User1
- Manufacturing, Packaging or Shipping Problem1
- Material Frayed1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Hemorrhage/Blood Loss/Bleeding2
- Insufficient Information2
- No Consequences Or Impact To Patient2
- No Patient Involvement2
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Product Quality Problem
IT WAS REPORTED TO INTERVASCULAR THAT THE DOCTOR OBSERVED THE PRESENCE OF A DEPOSIT INSIDE THE TUBE USED IN AORTIC SURGERY. THE TUBE WAS RINSED WITH SALINE SOLUTION, BUT THE DEPOSIT PERSISTED. COMPLAINT# (B)(4)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24857255 ↗DeathJan 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED TO INTERVASCULAR THAT DURING A CONVERSATION BETWEEN THE SALES REPRESENTATIVE AND THE HOSPITAL PHARMACIST ON DECEMBER 06, 2024, INFORMATION ABOUT A PATIENT'S DEATH WAS COMMUNICATED, PRESUMABLY FOLLOWING THE IMPLANTATION OF A CARDIOROOT PROSTHESIS IN (B)(6) 2023 (EXACT DAY NOT SPECIFIED). AT THE TIME OF THIS EMDR, THERE IS NO FURTHER INFORMATION ON THE CASE AND AN APPOINTMENT BETWEEN THE SALES REPRESENTATIVE AND THE SURGEON IS PENDING. IT SHOULD BE NOTED THAT THE DATE OF EVENT IN BLOCK B3 IS SET TO MAY 1, 2023, AS AN APPROXIMATION OF THE EVENT DATE. THE DATE WILL BE UPDATED LATER IN A FOLLOW-UP REPORT AS MORE INFORMATION WILL BECOME AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 21063480 ↗DeathDec 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MalfunctionJan 30, 2024Flaked; Flaked
COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18610832 ↗MalfunctionJan 24, 2024Flaked; Flaked
IT WAS REPORTED TO INTERVASCULAR THAT THE CARDIOROOT WAS CUT IN TWO PARTS AND WHEN USING THE DISTAL PART OF THE PROSTHESIS FOR WRAPPING, THE SURGEON NOTICED THE PRESENCE OF DEBRIS AND INTRA-PROSTHETIC FRAGMENTS RESEMBLING COLLAGEN WITH EMBOLISM RISK. THE WRAPPING WAS DONE NEVERTHELESS. ADDITIONAL INFORMATION RECEIVED FROM THE INITIAL REPORTER INDICATES THAT THE ISSUE WAS NOTICED DURING A TIRONE DAVID PROCEDURE WHEN THE INVOLVED FRAGMENT WAS OPENED TO WRAP THE DISTAL (EXTRA-VASCULAR) ANASTOMOSIS. NO DEFECTS WERE OBSERVED ON THE IMPLANTED FRAGMENT. THE SURGERY WAS NOT DELAYED AND NO CONSEQUENCES WERE REPORTED ON THE PATIENT. MOREOVER, THE SURGEON IS NOT A NEW USER OF CARDIOROOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18572740 ↗InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED TO INTERVASCULAR THAT A CARDIOROOT HAS BEEN IMPLANTED WITH A 27MM EDWARDS INSPIRIS VALVE. THE FOLLOWING DAY, IT WAS REPORTED THAT THE PATIENT WENT BACK TO THEATRE TO ESTABLISH HAEMOSTASIS. THERE WAS A BLEEDING REQUIRING REOPERATION. THE IMPLANTATION TECHNIQUE IS 6 POLYPROPYLENE STAY SUTURES TO ATTACH CARDIOROOT WITH VALVE. IMPLANTED WITH A CONTINUOUS POLYPROPYLENE SUTURE AS PER HIS VALSALVA TECHNIQUE. COMPLAINT # (B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15162950 ↗InjuryJul 27, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS REPORTED TO INTERVASCULAR THAT A CARDIOROOT HAS BEEN IMPLANTED WITH A 27 MM EDWARDS INSPIRIS VALVE. THE FOLLOWING DAY, IT WAS REPORTED THAT THE PATIENT WENT BACK TO THEATRE TO ESTABLISH HAEMOSTASIS. THERE WAS A "BLEEING" REQUIRING REOPERATION. THE IMPLANTATION TECHNIQUE IS 6 POLYPROPYLENE STAY SUTURES TO ATTACH CARDIOROOT WITH VALVE. IMPLANTED WITH A CONTINUOUS POLYPROPYLENE SUTURE AS PER HIS VALSALVA TECHNIQUE. COMPLAINT #(B)(4).
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 15112493 ↗InjuryJun 7, 2021Flaked; Flaked
SEE INITIAL MFG REPORT NUMBER : # 1640201-2021-00018. COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11950701 ↗InjuryJun 4, 2021Flaked; Flaked
SEE INITIAL MFG REPORT NUMBER : # 1640201-2021-00018. COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11938105 ↗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 1640201-2021-00003. COMPLAINT #(B)(4).
Patient problems: No Patient Involvement
MAUDE report 11284813 ↗MalfunctionMar 10, 2019Unraveled Material; Unraveled Material
IT WAS REPORTED THAT THE GRAFT HAD THREAD UNRAVELING ON ITS END. THE SURGEON CUT THE CLEAN AREA AND USED THE GRAFT. NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8406450 ↗MalfunctionSep 27, 2017Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THAT BEFORE A SURGERY, WHILE OPENING THE PACKAGING, THE DEVICE FOUND IN THE BOX WAS SIGNIFICANTLY DIFFERENT THAN THE LABELLED ONE. THE DEVICE HAS NOT BEEN USED HAS BEEN RETURNED FOR EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 6896792 ↗InjuryMar 24, 2017Material Frayed; Material Frayed
IT WAS REPORTED THAT ON (B)(6) 2017, DURING A CARDIAC SURGERY, THE INVOLVED GRAFT FRAYED. THE SURGEON WAS CREATING A BIO BENTALL WITH THE INVOLVED GRAFT AND A MAGNA HEART VALVE. THE SURGEON REPORTED THAT IT NECESSITATED STOPPING TWICE TO DEAL WITH THE FRAYING OF THE GRAFT. ACCORDING TO THE SURGEON, THE PATIENT WAS QUITE ILL WITH EJECTION FRACTION 25% AND THE ADDED CARDIAC ISCHEMIC TIME AND CARDIOPULMONARY BYPASS (CPB) TIME RELATED TO THIS GRAFT ISSUE WAS SEVERELY SUBOPTIMAL. IN THE SURGEON'S ESTIMATION IT EXTENDED HIS CARDIAC ISCHEMIC PERIOD OF HIS ALREADY COMPROMISED HEART BY 10-15 MINUTES AND ALSO HIS CPB TIME IF THE GRAFT HAD FRAYED ANY MORE. THE SURGERY WAS COMPLETED WITH THE INVOLVED GRAFT, AND NO ADVERSE OUTCOME FOR THE PATIENT WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6431450 ↗
Other Prosthesis, Vascular Graft, Of 6mm And Greater Diameter devices
- 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
- Cardioroot HEWROOT0028Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall6 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 · each recall links to the FDA recall notice
- 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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