HeRO® 00884450554395Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
All models of HeRO (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450554395), received between Jan 20, 2026 and Jan 20, 2026 — classified as 2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Pseudoaneurysm1
- Reduced Blood Flow1
- Thrombosis/Thrombus1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
THE PUBLICATION BY GARCÍA MENOR ET AL. (2025) DESCRIBES A CASE OF HERO GRAFT THROMBOSIS RESULTING IN DECREASED DIALYSIS FLOW AND REQUIRING ANGIOPLASTY AND PHARMACOMECHANICAL THROMBECTOMY. THE EVENT OCCURRED DURING CLINICAL USE OF THE DEVICE AND RESOLVED FOLLOWING INTERVENTION, WITH CONTINUED GRAFT PATENCY REPORTED ON FOLLOW-UP.
Patient problems: Reduced Blood Flow; Thrombosis/Thrombus
MAUDE report 24119187 ↗InjuryJan 20, 2026Adverse Event Without Identified Device or Use Problem
THE PUBLICATION BY KONG ET AL. (2025) ALLEGES HERO GRAFT-ASSOCIATED COMPLICATIONS, INCLUDING DEVICE-RELATED INFECTIONS AND PSEUDOANEURYSM FORMATION REQUIRING CLINICAL INTERVENTION. THESE EVENTS OCCURRED DURING ROUTINE CLINICAL USE OF THE HERO GRAFT IN THE UNITED STATES AND WERE MANAGED ACCORDING TO STANDARD MEDICAL PRACTICE.
Patient problems: Pseudoaneurysm; Unspecified Infection
MAUDE report 24119184 ↗
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
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- ADVANTA SLIDER GDS 22222Atrium 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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