Bayer Medical Care, Inc. recalls Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with th…

Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.

Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad¿ Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648;

On April 24, 2026, URGENT MEDICAL DEVICE RECALL letters were sent to customers. Customers were instructed to immediately halt the use of the affected product and review inventory for impacted product and quarantine. A Return Goods Authorization will be sent to return any remaining affected inventory. Place the affected product in a box and label the outside of the container with the RGA number provided and RECALL ID: SA-2026-RAD-03 in large, bold writing. Use the shipping label provided via email when you receive your RGA number. Please return the affected product as soon as possible. Please distribute this letter to other appropriate departments and personnel within your facility who may need awareness of this recall.

• FDA enforcement recordOfficial FDA database entry for Z-2296-2026
• FDA 510(k) clearance · K050456The device's official FDA premarket clearance record
• FDA device classification · DXTOfficial FDA classification for this device type
• CFR regulation · 21 CFR 870.1650The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Bayer Medical Care, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.