Public recall detail

Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets

2026-05-14

medium
Cardiovascular Performance
Quick summary

Quick summary: Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets. Reason: Performance. Category: Cardiovascular. Date: 2026-05-14.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Avanta Fluid Injection System - Multi-Patient Sterile Disposable Sets. Reason: Performance. Category: Cardiovascular. Date: 2026-05-14.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandBayer Medical Care Inc. Also Doing Business As Medrad, Inc.
ProductAvanta Fluid Injection System - Multi-Patient Sterile Disposable Sets
IssueMedical devices - Performance
Recall classType II
IdentificationRA-82073

Affected products

ProductAvanta Fluid Injection System - Multi-Patient Sterile Disposable Sets
Lot253304
ModelAVA 500 MPAT
Serial number253304
DescriptionAvanta Fluid Injection System - Multi-Patient Sterile Disposable Sets
ProductAvanta Fluid Injection System - Multi-Patient Sterile Disposable Sets
Lot252602
ModelAVA 500 MPAT
Serial number252602
DescriptionAvanta Fluid Injection System - Multi-Patient Sterile Disposable Sets

Issue

In April 2025, an off-the-shelf stopcock used in the Avanta Multi-Patient Administration Tube sets (AVA 500 MPAT (part 2 of 2)) was revised by the supplier to achieve ISO 80369-7 compliance and ensure connectability to other connectors. These changes resulted in a fit issue with the CFCV interface on the Avanta injector system. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the Contrast Flow Control Valve (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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Cardiovascular
CompaniesBayer Medical Care Inc. Also Doing Business As Medrad, Inc. 1 Bayer Drive, Indianola, Pennsylvania, United States, 15051
Recall date2026-04-24
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82073
Background{}
CompaniesBayer Medical Care Inc. Also Doing Business As Medrad, Inc. 1 Bayer Drive, Indianola, Pennsylvania, United States, 15051
AudiencesHealthcare
Source updated2026-05-14

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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