Recall Z-2296-2026 ยท DXT Injector And Syringe, Angiographic
Bayer Medical Care, Inc.
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;
| Date | Jun 3, 2026 (initiated Apr 24, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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 d |
| Quantity | 11,300 units (1650 US, 9650 OUS) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050456 | MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM Medrad, Inc., Jun 17, 2005 |