Boston Scientific Rapid Refill System: Risk of Syringe Disconnect During Use
Boston Scientific recalls Rapid Refill Continuous Injection System (UPN M00566001) due to risk of syringe loosening or disconnecting from the manifold, potentially causing fluid leakage or procedure delays.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Boston Scientific is recalling a specific model of Rapid Refill Continuous Injection System because the syringe can loosen or disconnect from the system during use. This may cause fluid leakage, difficulty connecting, or the need to exchange the device, which could prolong medical procedures. Read more at govinfonow.com/recall/49001-boston-scientific-rapid-refill-system-risk-of-syringe-disconnect-during.
Source Summary by GovInfoNow · govinfonow.com/recall/49001-boston-scientific-rapid-refill-system-risk-of-syringe-disconnect-during · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2725-2026
Cite this page
“Boston Scientific Rapid Refill System: Risk of Syringe Disconnect During Use.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/49001-boston-scientific-rapid-refill-system-risk-of-syringe-disconnect-during. Based on FDA recall #Z-2725-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2725-2026%22&limit=1).
Why it’s dangerous
The recalled syringe can loosen or disconnect from the manifold during use, leading to fluid leakage, inability to properly inject or aspirate, or separation of the syringe from the system. This may require device exchange and delay medical procedures.
Who’s affected
Medical professionals using the Rapid Refill Continuous Injection System with the specified model numbers are affected. Those performing procedures requiring this system are most at risk.
How to tell if you have this one
Check for the product name 'Rapid Refill Continuous Injection System' with the model number UPN M00566001. The specific lot numbers listed in the recall notice are also part of this recall.
- Brand
Boston Scientific- Category
Medical device
What to do — step by step
Check Device Model
Verify the model number on your device to see if it matches UPN M00566001.
Contact Manufacturer
Reach out to Boston Scientific for guidance on next steps if your device is affected.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution. OUS consignee list pending.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 22 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2725-2026 (June 30, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2725-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.