HeRO® 00884450564325Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450564325), received between Nov 27, 2023 and Mar 3, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Connection Problem” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 3, 2026Connection Problem

  CUSTOMER ALLEGED THAT DURING A PREVIOUS CASE, APPROXIMATELY ONE MONTH AFTER INSERTION, THE ARTERIAL COMPONENT OF A MERIT SUPERHERO GRAFT BECAME LOOSE FROM THE ADAPTOR AND THE VENOUS OUTFLOW COMPONENT POSITION CHANGED. THE DEVICE CANNOT BE RETURNED, AS THIS WAS AN EMERGENCY CASE. THE DOCTORS DISPOSED OF IT AFTER IT WAS EXCHANGED. THE PATIENT REMAINED STABLE, BUT EMERGENCY TREATMENT WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498524 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ACCOUNT ALLEGES THAT DURING A VENOUS OUTFLOW COMPONENT (VOC) GRAFT PLACEMENT ON (B)(6) 2023, THE GRAFT WAS INSERTED INTO THE PATIENT'S INTERNAL JUGULAR [IJ] VEIN. THE CLINICAL TEAM FAILED TO ACQUIRE HEMOSTASIS FOLLOWING INSERTION, SO THE VOC WAS REMOVED. BOTH PHYSICIANS INVOLVED [IR PHYSICIAN AND SURGEON] ARE INDEED EXPERIENCED IN VOC INSERTION PROCEDURES. GENERAL ANESTHESIA WAS USED FOR THIS PROCEDURE. BALLOON DILATATION WAS USED PRIOR TO SHEATH PLACEMENT, AND PRIOR TO THE EXCESSIVE BLOOD LOSS EVENT. EXCESSIVE BLEEDING WAS NOTED AROUND THE SHEATH AREA FOLLOWING PLACEMENT. THE INTERVENTIONAL RADIOLOGIST AND SURGEON BOTH ATTEMPTED TO MINIMIZE THE BLOOD LOSS FOR APPROXIMATELY 3-4 HOURS. ADDITIONAL BALLOONING TECHNIQUES TO CONTROL THE BLOOD LOSS WERE ATTEMPTED UNDER FLUOROSCOPY. THE PATIENT WAS TEMPORARILY STABLE FOR A TIME BUT, FURTHER SURGICAL INTERVENTION WAS NECESSARY AS THE PATIENT CONTINUED TO HEMORRHAGE. A HEAD AND NECK SURGEON WAS CONSULTED AND ASSISTED WITH BLOOD LOSS TECHNIQUES. BLOOD TRANSFUSIONS WERE STARTED DURING THE PROCEDURE AND CONTINUED POST-PROCEDURE. ON TUE (B)(6) 2023, THE PATIENT REQUIRED FURTHER CARDIOTHORACIC SURGICAL INTERVENTION. THE PATIENT EXPIRED IN TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18212394 ↗