HeRO® 00884450386514Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450386514), received between Jun 26, 2023 and Jun 26, 2023 — classified as 1 injury.
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
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE ACCOUNT ALLEGES THAT A PATIENT DIAGNOSED WITH CENTRAL VENOUS STENOSIS DIED IN THE ICU POST PROCEDURE. THE PROCEDURE WAS THE IMPLANTATION OF A PROSTHETIC VASCULAR GRAFT. DURING INSERTION, THE DEVICE WAS BECAME STUCK WHEN INSERTING IN THE PEEL-AWAY SHEATH. A NEW PEEL-AWAY SHEATH WAS TESTED AND THE GRAFT WAS STUCK AGAIN AND COULD NOT BE RELEASED. THE PATIENT'S BLOOD PRESSURE STARTED TO FALL. RESUSCITATION WAS REQUIRED, THE PATIENT'S HEARTBEAT RETURNED AFTER AN ELECTRIC SHOCK, AND THE OPERATION WAS STOPPED. THE PATIENT WAS TRANSFERRED TO ICU AND RECEIVED A BLOOD TRANSFUSION. CAUSE OF DEATH IS UNKNOWN.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 17205222 ↗
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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