Cardioroot HEWROOT0028Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00384401013907), received between Jan 13, 2016 and May 19, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Frayed” (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

1. 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryOct 13, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR FROM THE HEALTH FACILITY THAT: "THERE WAS AN INCIDENT DURING A BENTALL PROCEDURE: A CARDIOROOT PROSTHESIS WAS PUT IN PLACE. THE PROXIMAL PART OF THE TUBE WHERE THE CORONARIES ARE REIMPLANTED WAS DEEMED TO BE TOO POROUS AND FRAGILE, WHICH LED TO SMALL TEARS IN THE WIRES. HEMOSTASIS WAS VERY COMPLICATED AT THE END OF THE PROCEDURE WITH A REFITTING OF THE CEC, RE-CLAMPING OF THE AORTA AND THE MULTIPLE USE OF COAGULATION FACTORS AND BIOGLUE IN PARTICULAR. ON (B)(6) 2022, THE INSTITUTION INDICATED THAT THE PATIENT HAS BEEN ADMITTED TO THE INTENSIVE CARE UNIT. THE DEVICE WILL NOT BE AVAILABLE FOR EXPERTISE (IT REMAINED ON THE PATIENT)." COMPLAINT #(B)(4).

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15596615 ↗
• InjuryOct 10, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED TO INTERVASCULAR FROM THE HEALTH FACILITY THAT: "THERE WAS AN INCIDENT DURING A BENTALL PROCEDURE: A CARDIOROOT PROSTHESIS WAS PUT IN PLACE. THE PROXIMAL PART OF THE TUBE WHERE THE CORONARIES ARE REIMPLANTED WAS DEEMED TO BE TOO POROUS AND FRAGILE, WHICH LED TO SMALL TEARS IN THE WIRES. HEMOSTASIS WAS VERY COMPLICATED AT THE END OF THE PROCEDURE WITH A REFITTING OF THE CEC, RE-CLAMPING OF THE AORTA AND THE MULTIPLE USE OF COAGULATION FACTORS AND BIOGLUE IN PARTICULAR. ON (B)(6) 2022, THE INSTITUTION INDICATED THAT THE PATIENT HAS BEEN ADMITTED TO THE INTENSIVE CARE UNIT. THE DEVICE WILL NOT BE AVAILABLE FOR EXPERTISE (IT REMAINED ON THE PATIENT)." (B)(4).

  Patient problems: Failure to Anastomose; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15571350 ↗
• MalfunctionMay 3, 2021Device Damaged Prior to Use; Device Damaged Prior to Use

  THIS IS A CASE OF A PRODUCT DAMAGED DURING TRANSPORTATION. THE CARRIER (DHL) PUT A BOX WITH WATER (WHO HAD LEECHES INSIDE) IN THE SAME TRANSPORTATION OF OUR PRODUCT. THIS BOX BROKE OPEN AND ALL THE LIQUID CAME ON THE CARDIOROOT PRODUCT. THEREFORE THE PRODUCT WAS DAMAGED WHEN IT ARRIVED AT THE END CUSTOMER. THE PRODUCT HAS THEN BEEN RETURNED TO THE MANUFACTURER. COMPLAINT #(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11764682 ↗
• InjuryJan 13, 2016Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DURING AN AORTIC REPAIR VALVE REPLACEMENT PERFORMED ON (B)(6) 2015, SUTURE HOLE BLEEDING WAS NOTICED, WHICH REQUIRED THE USE OF HEMOSTATIC AGENT. THE GRAFT REMAINED IMPLANTED. THE PATIENT WAS REPORTED AS PROCESSING WELL.

  Patient problems: Blood Loss

  MAUDE report 5363396 ↗