Boston Scientific Rapid Refill Continuous Injection System recalled for syringe disconnection risk
What this means
Boston Scientific's Rapid Refill Continuous Injection System contains a recalled syringe component that may loosen or disconnect from the device manifold. This could result in fluid leakage, inability to inject or aspirate properly, or complete separation of the syringe, potentially requiring device replacement and extending the procedure.
- Check if your device matches one of the affected lot numbers listed in the recall.
- Contact Boston Scientific or your healthcare facility if your device is affected.
- Do not use affected devices; have them exchanged before the next procedure.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2725-2026More Boston Scientific recalls
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