HeRO® 00884450310151Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450310151), received between Mar 19, 2020 and Nov 4, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Material Separation2
- Detachment of Device or Device Component1
- Migration1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2020Material Separation; Migration; Material Separation; Migration
THE ACCOUNT ALLEGES THAT DURING A LONG-TERM HEMODIALYSIS DE-CLOTTING PROCEDURE, THE DISTAL OUTFLOW COMPONENTS RADIOPAQUE RING DETACHED WHILE DEPLOYING A 7MM X 40MM BALLOON WITHIN A CLOT LOCATED WITHIN THE HEMODIALYSIS OUTFLOW COMPONENT. THE ACCOUNT STATES THAT ALL BALLOON INFLATIONS WERE CLOSE TO THE OUTFLOW COMPONENT RADIOPAQUE MARKER BAND. POST BALLOON INFLATIONS, THE MARKER BAND DETACHED FROM THE COMPONENT BUT REMAINED ON THE GUIDEWIRE. A VASCULAR SNARE DEVICE WAS QUICKLY ADVANCED TO SUCCESSFULLY CAPTURE THE FOREIGN BODY FOR SAFE REMOVAL FROM THE PATIENT. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10785308 ↗MalfunctionMar 19, 2020Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT DURING A THROMBECTOMY PROCEDURE USING A BALLOON TO CLEAR THE EXCESSIVE THROMBUS FROM THE VENOUS OUTPUT COMPONENT [VOC], THE DISTAL RING ON THE VOC DEVICE DETACHED AND MIGRATED TO THE PATIENT'S LUNG. A NEW VOC WAS PLACED FOR CONTINUED TREATMENT. THE PATIENT TOLERATED THE PROCEDURE WELL AND REMAINED ASYMPTOMATIC. NO ADDITIONAL PROCEDURES HAVE BEEN SCHEDULED.
Patient problems: Foreign Body In Patient
MAUDE report 9857530 ↗
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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