Events

Recall of Device Recall MEDRAD Avanta Fluid Management Injection System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medrad Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    59167
  • Event Risk Class
    Class 2
  • Event Number
    Z-2866-2011
  • Event Initiated Date
    2011-06-02
  • Event Date Posted
    2011-07-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101479
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Injector and syringe, angiographic - Product Code DXT
  • Reason
    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.
  • 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.

Device

Device Recall MEDRAD Avanta Fluid Management Injection System
  • Model / Serial
    Catalog numbers: AVA 500 TABL, AVA 500 PEDL
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    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.
  • Manufacturer
    Medrad Inc

Manufacturer

Medrad Inc
  • Manufacturer Address
    Medrad Inc, 1 Medrad Dr, Indianola PA 15051-9759
  • Source
    USFDA