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HeRO® Graft Accessory Component Kit

Artivion, Inc. · Model HERO 1003 · UDI-DI 00877234000089

MSD LJS DSY Prescription

510(k) clearances

11,458

Adverse events (302 deaths)

270

Recalls

Facilities

Description

The HeRO (Hemodialysis Reliable Outflow) Graft is a long-term access solution for access-challenged and catheter-dependent patients. HeRO Graft is a fully subcutaneous surgical implant. It provides arterial venous (AV) access with continuous outflow into the central venous system. HeRO Graft traverses central venous stenosis allowing for long-term hemodialysis access. HeRO Graft consists of two primary components: • A proprietary Venous Outflow Component • A proprietary Arterial Graft Component The HeRO Graft Accessory Components provides instruments and accessories (such as, peel away sheaths and dilators, stylet, disposable clamp, hemostasis plug and hemostatic Y-valve with stopcock) that may aid in the placement of the HeRO Graft.

Recalls

Date	Firm	Reason
2026-04-10	ARROW INTERNATIONAL, LLC	16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-04-10	ARROW INTERNATIONAL, LLC	16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-04-10	ARROW INTERNATIONAL, LLC	16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-04-10	ARROW INTERNATIONAL, LLC	16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and
2026-02-13	Merit Medical Systems, Inc.	16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2026-02-13	Merit Medical Systems, Inc.	16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2026-02-13	Merit Medical Systems, Inc.	16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2026-02-13	Merit Medical Systems, Inc.	16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thromb
2025-04-23	Mozarc Medical US LLC	Potential breach of sterile barrier packaging.
2025-04-23	Mozarc Medical US LLC	Potential breach of sterile barrier packaging.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.