HeRORecalls & reported problems across all models
Merit Medical Systems, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 64
- Deaths reported
- 2
- Injuries reported
- 54
- Recalls
- 0
We found 12 models of HeRO by Merit Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 64 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2020 and Sep 22, 2026 — classified as 2 deaths, 54 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Migration” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported HeRO problems
Device problems
- Adverse Event Without Identified Device or Use Problem41
- Migration9
- Material Separation4
- Patient Device Interaction Problem4
- Obstruction of Flow3
- Connection Problem2
- Material Fragmentation2
- Material Split, Cut or Torn2
Patient problems
- Thrombosis/Thrombus31
- No Clinical Signs, Symptoms or Conditions9
- Unintended Loss of Vascular Access9
- Unspecified Infection6
- Stenosis5
- Foreign Body In Patient3
- Failure of Implant2
- Hemorrhage/Blood Loss/Bleeding2
HeRO models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- HeRO® 00884450563922PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 deaths36 reports
- HeRO® 00884450563915PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER9 reports
- HeRO® 00884450386521PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER4 reports
- HeRO® 00884450310151PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- HeRO® 00884450320563PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- HeRO® 00884450385685PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- HeRO® 00884450554395PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- HeRO® 00884450563908PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER2 reports
- HeRO® 00884450564325Catheter, Hemodialysis, Implanted2 reports
- HeRO® 00884450329559PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- HeRO® 00884450386514PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 report
- HeRO® AProsthesis, Vascular Graft, Of 6mm And Greater Diameter1 report
Recent HeRO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
The subject in a clinicial trial was experiencing a confirmed graft occlusion on (b)(6) 2026. Plan is to get blood pressure better controlled and then revise HERO as low blood pressure is suspected cause.
Patient problems: Obstruction/Occlusion
MAUDE report 50854143 ↗InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
The subject in a Merit HeRO graft clinicial trial experienced was seen at dialysis on (b)(6) 2026 no bruit/thrill. Seen in clinic (b)(6) 2026 with thrombosed Hero graft. Revision with thrombectomy (b)(6) 2026.
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 50689687 ↗MalfunctionAug 21, 2026Fluid/Blood Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50372812 ↗InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem
The subject in a Merit HeRO graft clinical trial experienced difficulty with dialysis on (b)(6) 2026 with infiltration and subsequent loss of thrill. Patient was seen in clinic and thrombosis verified. Patient had HERO revision and thrombectomy on (b)(6) 2026.
Patient problems: Infiltration into Tissue; Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 50052738 ↗DeathJul 28, 2026Adverse Event Without Identified Device or Use Problem
The subject in a Merit HeRO graft clinicial trial was admitted on (b)(6)2026 for acute on chronic hypoxic respiratory failure. On (b)(6)2026, a code was called for agonal breathing and profound bradycardia that became pulseless electrical activity (PEA) arrest. Cardiopulmonary resuscitation (CPR) was initiated on the patient resulting in intubation and transfer to the intensive care unit (ICU). Subject continued to experience profound bradycardia and PEA arrest despite several rounds of IV medications/fluids and the use of a LUCAS device. Subject coded multiple times for over a period of 5 hours. All efforts were eventually deemed futile and stopped. The patient expired.
Patient problems: Respiratory Failure
MAUDE report 50052736 ↗InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A SUBJECT IN A CLINICAL TRIAL, 508-013, EXPERIENCED DIFFICULTY WITH DIALYSIS WITH INFILTRATION AND LOSS OF THRILL. THROMBOSIS WAS VERIFIED IN CLINIC REQUIRING THROMBECTOMY AND REVISION OF THE HERO DEVICE.
Patient problems: Thrombosis/Thrombus
MAUDE report 25882454 ↗InjuryJun 23, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY, OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION THAT WAS POSSIBLY RELATED TO THE HERO GRAFT.
Patient problems: Thrombosis/Thrombus
MAUDE report 25597933 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED THROMBOSIS OF HERO GRAFT. PATIENT REFERRED TO ACCESS CENTER. PATIENT HAD THROMBECTOMY AND ANGIOPLASTY PERFORMED TO CLEAR THROMBOSIS. PATIENT CAN USE GRAFT IMMEDIATELY.
Patient problems: Thrombosis/Thrombus
MAUDE report 25472560 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED THROMBOSIS OF HERO GRAFT. PATIENT REFERRED TO ACCESS CENTER. PATIENT WAS SENT TO DIALYSIS CENTER FOR DECLOT. THROMBECTOMY AND ANGIOPLASTY PERFORMED. GRAFT IS READY FOR IMMEDIATE USE.
Patient problems: Thrombosis/Thrombus
MAUDE report 25472554 ↗InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED LOW FLOWS OF HERO GRAFT AT DIALYSIS AND WAS SENT TO ACCESS CENTER. PATIENT HAD ANGIOPLASTY OF DISTAL VENOUS GRAFT SEGMENT WITH GOOD RESULT. GRAFT IS READY FOR IMMEDIATE USE.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 25472550 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED THROMBOSIS OF THE VASCULAR ACCESS RESULTING IN LOSS OF FUNCTION (ABSENT THRILL) AND REQUIRING INTERVENTION TO RESTORE PATENCY. THE RELATIONSHIP TO THE STUDY DEVICE IS ASSESSED AS "POSSIBLE," AND DEVICE CONTRIBUTION CANNOT BE EXCLUDED. THROMBOSIS REQUIRING THROMBECTOMY AND ANGIOPLASTY IS A CLINICALLY SIGNIFICANT EVENT DIRECTLY RELATED TO THE INTENDED FUNCTION OF THE DEVICE.
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 25355748 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED LOW FLOW AT DIALYSIS AND WAS REFERRED TO AN ACCESS CENTER. THE NEXT DAY PATIENT HAD SUCCESSFUL ANGIOPLASTY.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 25351701 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED LOW FLOW AND WAS REFERRED TO AN ACCESS CENTER. THE NEXT DAY PATIENT HAD SUCCESSFUL ANGIOPLASTY.
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 25351696 ↗InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICIAL TRIAL EXPERIENCED LOW FLOW AND WAS REFERRED TO AN ACCESS CENTER. THE PATIENT HAD SUCCESSFUL ANGIOPLASTY.
Patient problems: Unintended Loss of Vascular Access
MAUDE report 25351695 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
THE SUBJECT IN A CLINICAL TRIAL EXPERIENCED CLOTTED ACCESS AT DIALYSIS WHICH ALLEGES DEFICIENCIES RELATED TO THE DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, AND PERFORMANCE OF THE DEVICE. PATIENT REFERRED TO ACCESS CENTER FOR DECLOT. PATIENT HAD SUCCESSFUL THROMBECTOMY AND ANGIOPLASTY ON (B)(6) 2026.
Patient problems: Thrombosis/Thrombus; Unintended Loss of Vascular Access
MAUDE report 25243532 ↗
Other Merit Medical Systems, Inc. products
- Aspira11 models · 36 reports · 10 recalls
- Impress145 models · 481 reports
- Monarch6 models · 37 reports · 7 recalls
- Bridge Prep Kit4 models · 6 reports · 3 recalls
- Prelude Roadster33 models · 1 reports · 3 recalls
- basixTOUCH6 models · 1 reports · 3 recalls
- basixCOMPAK34 models · 34 reports · 2 recalls
- Flex-Neck11 models · 21 reports · 2 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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