Boston Scientific Corporation — Class II: Rapid Refill Continuous Injection System, UPN M00566001
Boston Scientific Corporation has initiated a Class II recall for its Rapid Refill Continuous Injection System (UPN M00566001) because the system includes a recalled Medline Namic Angiographic Control Syringe. These syringes may loosen or disconnect from the manifold, causing fluid leakage, aspiration issues, or procedural delays.
Boston Scientific Corporation and clinical sites utilizing the Rapid Refill Continuous Injection System. Functional impacts extend to surgical staff, supply chain managers, and quality compliance officers.
This recall highlights the significant risk of secondary impacts when a third-party component is integrated into a larger system. The failure mode—disconnection from the manifold—poses direct risks to procedural efficiency and patient safety through potential air embolism or blood loss during angiography. This suggests that firms relying on sub-assemblies must maintain robust tracking to respond quickly to supplier-level enforcement actions.
Inventory teams should immediately identify and sequester affected UPN M00566001 units. Regulatory and QA departments should review supplier quality agreements and component change notification processes to ensure upstream recalls are identified and addressed promptly.
Class II. Reason: 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.. Product: Rapid Refill Continuous Injection System, UPN M00566001. Firm: Boston Scientific Corporation (Marlborough MA United States). Status: Ongoing.
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