Medium risk Medical DevicesClass II

Boston Scientific Rapid Refill Injection System Recall

Rapid Refill Continuous Injection System, UPN M00566001

Updated June 30, 2026

Boston Scientific's Rapid Refill Continuous Injection System contains a recalled syringe component that may loosen or disconnect from the manifold. This can cause fluid leakage, inability to inject or withdraw fluid properly, and may require stopping the procedure to exchange the device.

Is the Boston Scientific Corporation recalled? Yes. This product was recalled by FDA on June 30, 2026. Details below.

What is recalled

Rapid Refill Continuous Injection System, UPN M00566001, manufactured by Boston Scientific Corporation, which contains a recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor.

Am I affected

You are affected if you use or have a Rapid Refill Continuous Injection System with UPN M00566001 in a medical facility or clinic setting.

What to do right now

Contact Boston Scientific or your medical facility to report the device and arrange for an exchange or replacement. Do not use the device if you notice any loose connection, syringe wobbling, or difficulty connecting the syringe to the manifold.

The hazard

Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.

Brands affected

Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2725-2026
Classification
Class II
Recalled
June 30, 2026
Read the official notice

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