Rapid Refill Continuous Injection System, UPN M00566001

FDA device recall Z-2725-2026 · posted 2026-07-10 · Open, Classified

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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.

Action taken

On June 30, 2026, the firm began notifying US customers via letters titled "Urgent Medical Device Removal - Immediate Action Required." Customers were instructed to immediately stop further use or distribution of affected product, and segregate it. Continue to follow the standard care when monitoring patients treated with the contact. Product is to be returned to Boston Scientific.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

KYZ

Quantity affected

153,921 (US); 119,274 (OUS)

Distribution

US Nationwide distribution. OUS consignee list pending.

Date initiated

2026-06-30

Date posted

2026-07-10

Location

Marlborough, MA