Access-9 Hemostasis Valves Recalled for Guidewire Entrapment Risk

Plain-English summary

Merit Medical Systems is recalling approximately 36,445 Access-9 Large Bore Hemostasis Valves due to a manufacturing design defect.

The recalled devices contain an internal gap between the rotator and the Y-body component. This gap can cause the guidewire to become caught during use, resulting in difficulty advancing the guidewire through the valve. The defect may cause delays in medical procedures.

The affected devices have been distributed throughout the United States and in multiple countries internationally. Healthcare facilities and providers should identify affected lot numbers and discontinue use of the recalled devices. Replacement devices are available from Merit Medical Systems.

Patients who have undergone procedures using these devices should contact their healthcare provider if they have concerns about their treatment.

The recalled product

Product

Access-9 Large Bore Hemostasis Valves, Catalog Code: 580775001, IN8112/C, K05-00053H, K05-00109G, K05-00137K, K05-00410G, K05-00438G, K05-00502F, K05-00587D, K05-01052, K05-01706C, K05-01880K, K05-02130, K05-02595, K09-12599A, K10-05487P, K12-00264, MAP111/F, MAP112/B, MAP112/F,

Manufacturer

Merit Medical Systems, Inc.

Category

Medical Device — Vascular Access Hemostasis

Hazard

• design-defect
• guidewire-entrapment
• procedure-delay

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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