HeRO® 00884450563922Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of HeRO (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
The HeRO graft is an implanted vascular graft used to create dialysis access. Most of the 32 reports describe blood clots forming in the graft and problems at the access site, with patients needing procedures to open the graft, and some losing dialysis access entirely;30 injuries and 2 deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 36
- Deaths reported
- 2
- Injuries reported
- 33
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00884450563922), received between Apr 11, 2024 and Sep 22, 2026 — classified as 2 deaths, 33 injuries, 1 malfunction.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 reports).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem26
- Patient Device Interaction Problem4
- Obstruction of Flow3
- Connection Problem1
- Degraded1
- Disconnection1
- Fluid/Blood Leak1
- Material Erosion1
Patient problems
- Thrombosis/Thrombus22
- Unspecified Infection5
- Stenosis3
- Unintended Loss of Vascular Access3
- Obstruction/Occlusion2
- Abscess1
- Hemorrhage/Blood Loss/Bleeding1
- Infiltration into Tissue1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
The subject in a clinicial trial was experiencing a confirmed graft occlusion on (b)(6) 2026. Plan is to get blood pressure better controlled and then revise HERO as low blood pressure is suspected cause.
Patient problems: Obstruction/Occlusion
MAUDE report 50854143 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
The subject in a Merit HeRO graft clinicial trial experienced was seen at dialysis on (b)(6) 2026 no bruit/thrill. Seen in clinic (b)(6) 2026 with thrombosed Hero graft. Revision with thrombectomy (b)(6) 2026.
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 50689687 ↗MalfunctionAug 21, 2026Fluid/Blood Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50372812 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
The subject in a Merit HeRO graft clinical trial experienced difficulty with dialysis on (b)(6) 2026 with infiltration and subsequent loss of thrill. Patient was seen in clinic and thrombosis verified. Patient had HERO revision and thrombectomy on (b)(6) 2026.
Patient problems: Infiltration into Tissue; Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 50052738 ↗DeathJul 28, 2026Adverse Event Without Identified Device or Use Problem
The subject in a Merit HeRO graft clinicial trial was admitted on (b)(6)2026 for acute on chronic hypoxic respiratory failure. On (b)(6)2026, a code was called for agonal breathing and profound bradycardia that became pulseless electrical activity (PEA) arrest. Cardiopulmonary resuscitation (CPR) was initiated on the patient resulting in intubation and transfer to the intensive care unit (ICU). Subject continued to experience profound bradycardia and PEA arrest despite several rounds of IV medications/fluids and the use of a LUCAS device. Subject coded multiple times for over a period of 5 hours. All efforts were eventually deemed futile and stopped. The patient expired.
Patient problems: Respiratory Failure
MAUDE report 50052736 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED THROMBOSIS OF HERO GRAFT. PATIENT REFERRED TO ACCESS CENTER. PATIENT HAD THROMBECTOMY AND ANGIOPLASTY PERFORMED TO CLEAR THROMBOSIS. PATIENT CAN USE GRAFT IMMEDIATELY.
Patient problems: Thrombosis/Thrombus
MAUDE report 25472560 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED LOW FLOWS OF HERO GRAFT AT DIALYSIS AND WAS SENT TO ACCESS CENTER. PATIENT HAD ANGIOPLASTY OF DISTAL VENOUS GRAFT SEGMENT WITH GOOD RESULT. GRAFT IS READY FOR IMMEDIATE USE.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 25472550 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED THE SYMPTOMS (PAIN, SWELLING, AND INABILITY TO CANNULATE) INDICATING AN ACCESS SITE COMPLICATIONS RESULTING IN LOSS OF FUNCTIONAL USE OF THE HERO IMPLANTED DEVICE AND NEED FOR ALTERNATIVE DIALYSIS ACCESS. THIS PATIENT HAD A HOSPITALIZATION AND PLACEMENT OF A TUNNELED DIALYSIS CATHETER (TDC). THE REQUIRED INTERVENTION WAS ON APRIL 14TH, 2026.
Patient problems: Pain; Swelling/ Edema
MAUDE report 25163787 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED RECURRENCE OF THROMBOSIS OF THE HERO GRAFT, REQUIRING INTERVENTION TO MAINTAIN ACCESS PATENCY. THE REQUIRED INTERVENTION WAS ON (B)(6) 2026.
Patient problems: Thrombosis/Thrombus
MAUDE report 25163778 ↗InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED THROMBOSIS OF THE HERO GRAFT, REQUIRING INTERVENTION TO MAINTAIN ACCESS PATENCY. THE REQUIRED INTERVENTION WAS ON (B)(6) 2026.
Patient problems: Thrombosis/Thrombus
MAUDE report 25163775 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6), 2026, INFORMATION WAS RECEIVED REGARDING A SUBJECT PARTICIPATING IN A CLINICAL TRIAL. THE SUBJECT EXPERIENCED THROMBOSIS REQUIRING MEDICAL INTERVENTION, INCLUDING THROMBECTOMY, ANGIOPLASTY, AND STENT PLACEMENT. THESE INTERVENTIONS WERE PERFORMED TO RESTORE ACCESS PATENCY. THE PATIENT OUTCOME FOLLOWING INTERVENTION WAS NOT REPORTED.
Patient problems: Thrombosis/Thrombus
MAUDE report 25049000 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ON APRIL 15, 2026, INFORMATION WAS RECEIVED REGARDING A SUBJECT PARTICIPATING IN A CLINICAL TRIAL. THE SUBJECT EXPERIENCED COMPLICATIONS RELATED TO THE HERO GRAFT, SPECIFICALLY THROMBOSIS REQUIRING INTERVENTIONAL DECLOT PROCEDURES. DETAILS REGARDING THE SPECIFIC INTERVENTIONS AND PATIENT OUTCOME WERE NOT PROVIDED.
Patient problems: Thrombosis/Thrombus
MAUDE report 25048095 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, INFORMATION WAS RECEIVED REGARDING A SUBJECT PARTICIPATING IN A CLINICAL TRIAL. THE SUBJECT EXPERIENCED COMPLICATIONS RELATED TO THE HERO GRAFT, SPECIFICALLY THROMBOSIS REQUIRING INTERVENTIONAL DECLOT PROCEDURES. DETAILS REGARDING THE SPECIFIC INTERVENTIONS AND PATIENT OUTCOME WERE NOT PROVIDED.
Patient problems: Thrombosis/Thrombus
MAUDE report 25048086 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ON APRIL 8, 2026, INFORMATION WAS RECEIVED REGARDING A SUBJECT PARTICIPATING IN A CLINICAL TRIAL. THE SUBJECT EXPERIENCED THROMBOSIS OF THE HERO GRAFT REQUIRING MEDICAL INTERVENTION, INCLUDING THROMBECTOMY AND ANGIOPLASTY. THE PATIENT OUTCOME FOLLOWING INTERVENTION WAS NOT FURTHER SPECIFIED.
Patient problems: Thrombosis/Thrombus
MAUDE report 25048064 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ON APRIL 8, 2026, INFORMATION WAS RECEIVED REGARDING A SUBJECT PARTICIPATING IN A CLINICAL TRIAL. THE SUBJECT EXPERIENCED THROMBOSIS OF THE HERO GRAFT REQUIRING MEDICAL INTERVENTION, INCLUDING THROMBECTOMY AND ANGIOPLASTY. THE PATIENT OUTCOME FOLLOWING INTERVENTION WAS NOT FURTHER SPECIFIED.
Patient problems: Thrombosis/Thrombus
MAUDE report 25048057 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ON APRIL 6, 2026, INFORMATION WAS RECEIVED REGARDING A SUBJECT PARTICIPATING IN A CLINICAL TRIAL. THE SUBJECT EXPERIENCED THROMBOSIS OF THE HERO GRAFT IN CONJUNCTION WITH IN-STENT STENOSIS. THE PATIENT OUTCOME WAS NOT REPORTED.
Patient problems: Stenosis; Thrombosis/Thrombus
MAUDE report 25048045 ↗InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
ON APRIL 1, 2026, INFORMATION WAS RECEIVED REGARDING A SUBJECT PARTICIPATING IN A CLINICAL TRIAL. THE SUBJECT EXPERIENCED THROMBOSIS OF THE HERO GRAFT REQUIRING MEDICAL INTERVENTION, INCLUDING THROMBECTOMY AND ANGIOPLASTY, TO RESTORE PATENCY. THIS EVENT REPRESENTS A RECURRENT THROMBOSIS IN THE SAME SUBJECT, NECESSITATING REPEAT INTERVENTION. THE PATIENT OUTCOME FOLLOWING INTERVENTION WAS NOT FURTHER SPECIFIED.
Patient problems: Thrombosis/Thrombus
MAUDE report 25048022 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED THROMBOSIS OF THE HERO GRAFT, REQUIRING INTERVENTION INCLUDING THROMBECTOMY AND ANGIOPLASTY TO RESTORE PATENCY.
Patient problems: Thrombosis/Thrombus
MAUDE report 24914727 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED A CLOTTED HERO GRAF ON (B)(6) 2026, AND THE PATIENT HAD A SUCCESSFUL DECLOT THE SAME DAY.
Patient problems: Thrombosis/Thrombus
MAUDE report 24914684 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED A CLOTTED HERO GRAFT ON 11JAN2026, AND THE PATIENT HAD AN ANGIOPLASTY PERFORMED ON (B)(6) 2026 WITH GOOD RESULTS.
Patient problems: Thrombosis/Thrombus
MAUDE report 24914683 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED IN-STENT RESTENOSIS WITH ASSOCIATED THROMBOSIS, REQUIRING PERCUTANEOUS INTERVENTION (ANGIOPLASTY) TO RESTORE PATENCY IN THE HERO GRAFT. PATIENT HAD ANGIOPLASTY TO OPEN UP IN-STENT STENOSIS SUCCESSFULLY.
Patient problems: Thrombosis/Thrombus
MAUDE report 24914681 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL WENT TO ACCESS CENTER ON (B)(6) 2026 AND HAD DECLOT WHICH INCLUDED A THROMBECTOMY, ANGIOPLASTY, AND STENT PLACEMENT TO STENOSIS. PROCEDURE WAS SUCCESSFUL.
Patient problems: Thrombosis/Thrombus
MAUDE report 24914668 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED A STENOSIST IN THE HERO GRAFT. PATIENT SENT TO ACCESS CENTER FOR DECLOT. DECLOT PERFORMED SUCCESSFULLY.
Patient problems: Stenosis
MAUDE report 24914667 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED A CLOTTED HERO GRAFT ON (B)(6) 2026, AND THE PATIENT HAD A SUCCESSFUL DECLOT THE (B)(6) 2026 WITH HEMODIALYSIS PERFORMED AFTERWARDS.
Patient problems: Thrombosis/Thrombus
MAUDE report 24914662 ↗InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED A THROMBUS IN THE HERO GRAFT, AND WAS SENT TO THE ACCESS CENTER FOR A DECLOT PROCEDURE. THE DECLOT WAS PERFORMED SUCCESSFULLY.
Patient problems: Thrombosis/Thrombus
MAUDE report 24914652 ↗
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
- 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
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium 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
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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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