CardiorootRecalls & reported problems across all models
Intervascular Sas · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Cardioroot model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 35
- Deaths reported
- 5
- Injuries reported
- 16
- Recalls
- 1
We found 6 models of Cardioroot by Intervascular Sas in the FDA's device registry (GUDID). Together they are named in 35 adverse event reports in the FDA's MAUDE database, received between Jan 13, 2016 and Apr 13, 2026 — classified as 5 deaths, 16 injuries, 14 malfunctions.
The most frequently reported specific device problem is “Flaked” (9 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Cardioroot recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 6 of these models · Recall details · FDA record ↗
Most reported Cardioroot problems
Device problems
- Flaked9
- Insufficient Device Problem Information6
- Material Frayed6
- Adverse Event Without Identified Device or Use Problem4
- Manufacturing, Packaging or Shipping Problem4
- Product Quality Problem3
- Delivered as Unsterile Product2
- Device Damaged Prior to Receipt by User2
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Hemorrhage/Blood Loss/Bleeding9
- No Consequences Or Impact To Patient4
- No Patient Involvement4
- Blood Loss2
- Failure to Anastomose2
- High White Blood Cell Count2
- Hypersensitivity/Allergic reaction2
Cardioroot models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Cardioroot HEWROOT0030Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- Cardioroot HEWROOT0032Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- Cardioroot HEWROOT0028Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall6 reports
- Cardioroot HEWROOT0026Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall4 reports
- Cardioroot HEWROOT0034Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall1 death2 reports
- Cardioroot HEWROOT0024Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall0 reports
Recent Cardioroot adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionMay 19, 2025Material Frayed; Material Frayed
IT WAS REPORTED TO INTERVASCULAR THAT UPON TAKEN THE GRAFT OUT OF THE PACKAGING WITHOUT PRODUCT HANDLING PRIOR USE, IT WAS NOTICED THAT PART OF THE COLLAR OF THE GRAFT WAS FRAYED. THE PROSTHESIS WAS IMPLANTED AND THE OPERATION WENT WELL. NO INJURIES WERE REPORTED ON THE PATIENT. COMPLAINT#: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043701 ↗MalfunctionJan 31, 2025Flaked; Material Frayed; Flaked; Material Frayed
IT WAS REPORTED TO INTERVASCULAR THAT DURING THE SURGICAL PROCEDURE, WHEN THE CARDIOROOT GRAFT WAS GOING TO BE SEWN IN AFTER CUTTING THE NECK AREA AFTER THE BULGE, THE SURGEON NOTICED CLUMPS OF THE GRAFT COATING PEELING FROM THE GRAFT ONTO GLOVES. THE GRAFT WAS TAKEN OFF THE FIELD AND NOT IMPLANTED PER SURGEON DECISION. THE PROCEDURE WAS SLIGHTLY DELAYED TO GET ANOTHER GRAFT (A PLATINUM 28MM STRAIGHT GRAFT) TO FINISH SURGERY. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21282059 ↗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
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
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 ↗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 ↗InjuryFeb 7, 2023Nonstandard Device; Nonstandard Device
InjuryJan 27, 2023Nonstandard Device; Nonstandard Device
Other Intervascular Sas products
All Intervascular Sas devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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