Z-2866-2011

MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL

Name: Z-2866-2011 MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL
Creator: Medrad Inc
Published: 2011-06-02
License: https://open.fda.gov/license/

Medrad, Inc. / initiated 2011-06-02 / Terminated / root cause: design

FDA source

Medrad Inc began a recall of MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque... on 2011-06-02. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2866-2011
Status: Terminated
Initiated: 2011-06-02
Posted: 2011-07-22
Terminated: 2012-06-05
Recalling firm: Medrad, Inc.
Product: MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic procedures.
Product code: DXT Injector And Syringe, Angiographic
Reason for recall: 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
Root cause tag: design
FDA root cause: Device Design
Action: Medrad Inc., sent two types of "MEDICAL DEVICE FIELD CORRECTION" notifications on June 2, 2011 to all affected customers. 1. To those customers who Avanta Systems have already undergone market withdrawal and thus have been upgraded, the notification provided customer awareness that prior action should be considered a field correction. The letter stated that NO action is required since their system(s) has already been upgraded. If you have any questions, concerning these activities contact the Director of Quality Systems at (724) 940-6905. 2. To those customers whose Avanta Systems have not yet been upgraded through market withdrawal, the notification informed customers that the recalling firm is undertaking a Field Correction to upgrade their system(s). The letter included a step by step guide that will allow customers to verify that their system(s) has NOT been upgraded. Customers are instructed to complete and fax this form to MEDRAD at (412) 406-0941. If you have any questions, concerning these activities contact the Product Manager at (412) 767-2400, extension 8401.
Quantity in commerce: 842
Distribution: Worldwide Distribution -- (USA) (nationwide) including the state of Puerto Ricoand the countries of: AE, AL, AT, BE, BG, BR, CA, CH, CO, CY, DE, DK, DO, ES, FI, FR, GB, HK, HR, HU, IE, IL, IS, IT, JO, JP, KR, KW, LY, MA, MT, MX, MY, NL, PA, PH, PK, PT, QA, RS, RU, SA, SE, SG, SI, TR, VI, and ZA.
Product codes and lots: Catalog numbers: AVA 500 TABL, AVA 500 PEDL

Product code DXT

K050456Class IIMedrad Avanta Fluid Management Injection SystemMedrad, Inc. / cleared 2005-06-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)