HeRO® 00884450386521Recalls & reported problems
Merit Medical Systems, Inc. · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450386521), received between Nov 4, 2020 and Mar 1, 2022 — classified as 2 injuries, 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. How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Migration2
- Crack1
- Fracture1
- Material Fragmentation1
Patient problems
- Cardiac Perforation1
- Foreign Body In Patient1
- Heart Failure/Congestive Heart Failure1
- Low Blood Pressure/ Hypotension1
- No Clinical Signs, Symptoms or Conditions1
- Stenosis1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMar 1, 2022Migration; Migration
THE ACCOUNT ALLEGES THAT A GRAFT WAS SUCCESSFULLY IMPLANTED IN (B)(6) 2021. ON (B)(6) 2022, DURING FOLLOW UP, IT WAS DISCOVERED THAT THE VENOUS OUTFLOW COMPONENT HAD MIGRATED OUT OF THE RIGHT ATRIUM AND IS CAUSING STENOSIS. THE ENTIRE GRAFT NEEDED TO BE EXPLANTED.
Patient problems: Stenosis
MAUDE report 13636548 ↗InjuryFeb 23, 2021Migration; Migration
UPON CONDUCTING A MAUDE DATABASE QUERY, THE FOLLOWING EVENT WAS DISCOVERED: A REPORTER STATED THAT DURING A GRAFT PLACEMENT THE DEVICE MIGRATED. THE REPORTER ALLEGES THAT THE MIGRATION CAUSED CARDIAC TISSUE DAMAGE, RESUSCITATION, AND ADDITIONAL SURGERY.
Patient problems: Cardiac Perforation; Heart Failure/Congestive Heart Failure; Low Blood Pressure/ Hypotension
MAUDE report 11364875 ↗MalfunctionNov 10, 2020Crack; Crack
THE ACCOUNT ALLEGES THAT DURING AN ANGIOGAM THE HERO GRAFT APPEARED HAZY WITH POSSIBLE CLOT OR CRACKING. DURING SURGERY THE HERO WAS CONFIRMED TO BE CRACKED, AND A REVISION OF THE HERO GRAFT WAS PERFORMED. THE NEW GRAFT IS REPORTED AS WORKING APPROPRIATELY. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10820161 ↗MalfunctionNov 4, 2020Fracture; Material Fragmentation; Fracture; Material Fragmentation
THE ACCOUNT ALLEGES THAT DURING THE IMPLANT OF THE HERO DEVICE, UPON REMOVING THE PEEL-AWAY SHEATH THE HUB DETACHED AND THE SHEATH WAS LEFT IN THE BODY AND MOVED DOWN THE IVC. THE SURGEON AND THE IR PHYSICIAN WERE ABLE TO RETRIEVE THE SHEATH FROM THE IVC. NO PATIENT INJURY TO REPORT.
Patient problems: Foreign Body In Patient
MAUDE report 10786096 ↗
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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