FDA recall, , Moderate risk
Bayer Avanta Multi-Patient Administration Tube Sets
Avanta Multi-Patient Administration Tube Sets have a fit issue with the valve interface, causing unstable connection.
Summary by Recall Canary from the FDA notice
What happened
Bayer Medical Care, Inc. of Indianola, Pennsylvania is recalling Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System. 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.
The recall began on April 24, 2026, and was added to the FDA's Enforcement Report on June 3, 2026. Distribution was worldwide, including US nationwide distribution in 28 states and other countries. The affected material numbers are 87629007, 60729458, and 86566648. The recall covers 11,300 units.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
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;- UDI-DI
- 87629007
- 60729458
- 86566648
- Lot code
- 251702
- 252302
- 252502
- 252602
- 252702
- 252802
- 253304
- 253702
- 253704
- 253804
- 254202
- 254304
- 254704
- 254802
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Wisconsin and the countries of AE, BA, BE, California, CH, CN, Delaware, DK, ES, FR, GB, HK, HR, Illinois, KW, Montana, MX, NL, RO, RU, SE, ZA.
- Company
- Bayer Medical Care, Inc.Indianola, Pennsylvania
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98881
- Recall number
- Z-2296-2026
- Quantity recalled
- 11,300 units (1650 US, 9650 OUS)
All recalls from Bayer Medical Care, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
