HeRO® 00884450563915Recalls & 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
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884450563915), received between Apr 30, 2026 and Jul 20, 2026 — classified as 9 injuries.
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 Problem9
Patient problems
- Thrombosis/Thrombus7
- Unintended Loss of Vascular Access5
- Stenosis1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SUBJECT IN A CLINICAL TRIAL, 508-013, EXPERIENCED DIFFICULTY WITH DIALYSIS WITH INFILTRATION AND LOSS OF THRILL. THROMBOSIS WAS VERIFIED IN CLINIC REQUIRING THROMBECTOMY AND REVISION OF THE HERO DEVICE.
Patient problems: Thrombosis/Thrombus
MAUDE report 25882454 ↗InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION THAT WAS POSSIBLY RELATED TO THE HERO GRAFT.
Patient problems: Thrombosis/Thrombus
MAUDE report 25597933 ↗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 WAS SENT TO DIALYSIS CENTER FOR DECLOT. THROMBECTOMY AND ANGIOPLASTY PERFORMED. GRAFT IS READY FOR IMMEDIATE USE.
Patient problems: Thrombosis/Thrombus
MAUDE report 25472554 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED THROMBOSIS OF THE VASCULAR ACCESS RESULTING IN LOSS OF FUNCTION (ABSENT THRILL) AND REQUIRING INTERVENTION TO RESTORE PATENCY. THE RELATIONSHIP TO THE STUDY DEVICE IS ASSESSED AS "POSSIBLE," AND DEVICE CONTRIBUTION CANNOT BE EXCLUDED. THROMBOSIS REQUIRING THROMBECTOMY AND ANGIOPLASTY IS A CLINICALLY SIGNIFICANT EVENT DIRECTLY RELATED TO THE INTENDED FUNCTION OF THE DEVICE.
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 25355748 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED LOW FLOW AT DIALYSIS AND WAS REFERRED TO AN ACCESS CENTER. THE NEXT DAY PATIENT HAD SUCCESSFUL ANGIOPLASTY.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 25351701 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED LOW FLOW AND WAS REFERRED TO AN ACCESS CENTER. THE NEXT DAY PATIENT HAD SUCCESSFUL ANGIOPLASTY.
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 25351696 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED LOW FLOW AND WAS REFERRED TO AN ACCESS CENTER. THE PATIENT HAD SUCCESSFUL ANGIOPLASTY.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 25351695 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED CLOTTED ACCESS AT DIALYSIS WHICH ALLEGES DEFICIENCIES RELATED TO THE DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, AND PERFORMANCE OF THE DEVICE. PATIENT REFERRED TO ACCESS CENTER FOR DECLOT. PATIENT HAD SUCCESSFUL THROMBECTOMY AND ANGIOPLASTY ON (B)(6) 2026.
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 25243532 ↗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 25048083 ↗
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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