Boston Scientific Corporation: Rapid Refill Continuous Injection System, Upn M00566001
Recall Summary Boston Scientific is recalling its Rapid Refill Continuous Injection System (model M00566001) because it contains a faulty syringe component that may loosen or disconnect from the device during use. This could prevent the syringe from working properly, cause fluid leaks, or separate from the system entirely, potentially requiring the device to be replaced during a medical procedure. The affected devices were distributed nationwide across all U.S. states and territories.
- Recalling firm
- Boston Scientific Corporation
- Product
- Rapid Refill Continuous Injection System, UPN M00566001
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-06-30
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide distribution. OUS consignee list pending.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/41a34080-44e7-41a3-86f4-5d099ca1a5c7