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MEDRAD® Avanta Fluid Management Injection System

by Bayer Medical Care Inc. EUDAMEDGUDID

Active European Union and United States

Ref AVA 500 SYRH

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0616258TFCN-0060I3B Basic UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00616258008585 UDI-DIDate24 Sep 2016ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

6 recalls · 1 ongoing · FDA

    • Ongoing Z-2296-2026 FDA Class II initiated 24 Apr 2026

    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.

    • Terminated Z-0870-2013 FDA Class II initiated 5 Nov 2012

    The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.

    • Terminated Z-2866-2011 FDA Unclassified (pre-2012) initiated 2 Jun 2011

    Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "Important Product Use Reminder" to remind users of proper procedures for using the system and the need for diligence in reducing air embo

    • Terminated Z-1199-2010 FDA Unclassified (pre-2012) initiated 6 Jan 2010

    The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging.

  • 2 recalls, same reason

    • Terminated Z-0083-06 FDA Unclassified (pre-2012) initiated 20 Sep 2005 via K050456, on the same 510(k)
    • Terminated Z-0082-06 FDA Unclassified (pre-2012) initiated 20 Sep 2005 via K050456, on the same 510(k)

    stress crack on the stopcock

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID

Generic Name
Angiography contrast medium injection system, line-powered, mobile
Model / Ref / Catalog
AVA 500 SYRH
Description
"ASSEMBLY, HEAT MAINTAINER, SYRINGE (85276670)"
Primary DI / UDI-DI
00616258008585
Basic UDI-DI
0616258TFCN-0060I3B
510(k) Number
FDA Product Code
DXT
EMDN Code
A030105 Fluids heating systems
GMDN Term
Angiography contrast medium injection system, line-powered, mobile
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1650
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000007050
Authorised representative
Bayer Medical Care B.V. NL-AR-000000240

Other devices from Bayer Medical Care Inc.

See all devices from Bayer Medical Care Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No