HeRO® 00884450320563Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 13, 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 00884450320563), received between Dec 1, 2020 and Apr 27, 2021 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Migration2
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 2021Material Fragmentation; Migration; Material Fragmentation; Migration
THE ACCOUNT ALLEGES THAT DURING A HEMODIALYSIS RELIABLE OUTFLOW GRAFT DE-CLOT PROCEDURE ON (B)(6) 2021 , THE PHYSICIAN NOTED THAT A DISTAL PART OF THE VOC PLACED WITHIN THIS PATIENT IN 2017 HAD DETACHED. ACCORDING TO RADIOLOGY IMAGES RECEIVED FROM THE ACCOUNT, APPROXIMATELY 5CM OF THE DISTAL VOC IS FREE FLOATING WITHIN THE PATIENT'S RIGHT VENTRICLE. INTERVENTION WILL BE REQUIRED FOR FOREIGN BODY REMOVAL. PATIENT WAS ADMITTED AND ASYMPTOMATIC.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 11734906 ↗InjuryDec 1, 2020Migration; Migration
THE ACCOUNT ALLEGES THAT THE HERO DEVICE DISCONNECTED FROM THE TITANIUM CONNECTION AND MIGRATED TO THE RIGHT VENTRICLE. COMPONENT WAS PARTIALLY REMOVED ON (B)(6) 2020. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10928955 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page