FDA-Device2026-07-22Class IIPROCESSING DEFECT

Boston Scientific Rapid Refill Continuous Injection System recalled for syringe disconnection risk

OTHERNationwide distribution

Boston Scientific injection system recalled for syringe disconnection risk

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.
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.

Sold states
US Nationwide distribution. OUS consignee list pending.
Affected count
153,921 (US); 119,274 (OUS)
Manufactured in
100 Boston Scientific Way, Marlborough, MA, United States
Products
Rapid Refill Continuous Injection System, UPN M00566001

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2725-2026

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