Bayer Medical Care, Inc.: Injector And Syringe, Angiographic

Recall Summary Bayer Medical Care is recalling Avanta Multi-Patient Administration Tube Sets used with Medrad Avanta Injection Systems because a supplier change caused a fit problem with the connection valve. The stopcock may not connect properly or may disconnect during use, which can interrupt medical procedures. The recall affects units distributed nationwide in the US and internationally.

Recalling firm: Bayer Medical Care, Inc.
Product: 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;
Reason: 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.
Classification: Class II
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-04-24
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DE, FL, IA, IL, IN, KS, KY, LA, MA, MD, ME, MO, NC, NY, OH, OK, PA, SC, TN, TX, VA, WI and the countries of AE, BA, BE, CA, CH, CN, DE, DK, ES, FR, GB, HK, HR, IL, KW, MT, MX, NL, RO, RU, SE, ZA.

Recall details on Nibble Recalls: https://trynibble.app/recalls/7a56d4d4-ca2d-4a37-bc8c-366bd30f2d9b