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OKAY® II Y-Connector Set

Nipro Vascular Innovations Americas, Inc. · Model YOK0A · UDI-DI 04543660022334

DTL Prescription

510(k) clearances

2,159

Adverse events (18 deaths)

Recalls

144

Facilities

Description

OKAY II reduces blood loss during procedures through the use of a hemostatic valve not featured on conventional Y connectors. Its large 3.33mm (10F) inner diameter facilitates a variety of PCI devices and techniques, and a new feature has been added that allows the one-touch style hemostatic valve to be locked in the open position. Includes Y-connector, torque device, and introducer. Indications for Use: 1. This product is designed to work in conjunction with guiding catheters, etc. to reduce blood loss while assisting in manipulation of catheters, etc., injection of contrast solution from a side port, injection of medicine or saline solution, and measurement of blood pressure.

Recalls

Date	Firm	Reason
2026-03-24	Medline Industries, LP	Medline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-24	Medline Industries, LP	Medline has identified the presence of particulate within the fluid path of the Manifolds.
2026-03-24	Medline Industries, LP	Medline has identified the presence of particulate within the fluid path of the Manifolds.
2026-02-27	Medline Industries, LP	Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection
2025-08-04	Merit Medical Systems, Inc.	Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemor
2025-07-25	Merit Medical Systems, Inc.	Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
2024-04-08	MEDLINE INDUSTRIES, LP - Northfield	Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma
2023-04-05	Boston Scientific Corporation	The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
2023-04-05	Boston Scientific Corporation	The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
2022-03-01	Merit Medical Systems, Inc.	A design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the guidewire can get caught, resulting in

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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.