HeRO® 00884450563908Recalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450563908), received between Jan 3, 2024 and Jan 3, 2024 — classified as 2 malfunctions.
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. 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
- Migration2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 3, 2024Migration; Migration
THE ACCOUNT ALLEGES THAT THE VENOUS OUTFLOW COMPONENT [VOC] HAD MIGRATED OUT OF POSITION. THE PHYSICIAN WAS ABLE TO REPOSITION THE VOC. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18441106 ↗MalfunctionJan 3, 2024Migration; Migration
THE ACCOUNT ALLEGES THAT APPROXIMATELY 2-3 WEEKS POST VENOUS OUTFLOW COMPONENT [VOC] IMPLANT PROCEDURE, THE VOC IMPLANT HAD MIGRATED OUT OF THE PATIENT'S RIGHT ATRIUM AND HAD ROTATED LATERALLY INSIDE THE PATIENT'S ARM JUST PAST THE PATIENT'S SHOULDER. THE PHYSICIAN ELECTED TO EXTRACT THE VOC ALONG WITH THE GRAFT FROM THE PATIENT'S ARM. THE PATIENT IS CURRENTLY RECEIVING DIALYSIS VIA A CENTRAL VENOUS CATHETER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18441102 ↗
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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