Events

Recall of Device Recall ACIST

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

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
    27388
  • Event Risk Class
    Class 2
  • Event Number
    Z-0064-04
  • Event Initiated Date
    2003-10-02
  • Event Date Posted
    2003-10-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29789
  • 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
    Some of the automated manifold's 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak.
  • Action
    The consignees were sent letters dated 10/2/03 which requested that the product be returned.

Device

Device Recall ACIST
  • Model / Serial
    Lot Numbers 0933A and 1003I
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide in the United States.
  • Product Description
    ACIST Automated Manifold (Transducer) Kit, Model BT2000, SKU #014613 (used with ACIST Contrast Management Systems (CMS2000) and E2000 Voyager Units)
  • Manufacturer
    Acist Medical Systems

Manufacturer

Acist Medical Systems
  • Manufacturer Address
    Acist Medical Systems, 7450 Flying Cloud Dr., Suite 150, Eden Prairie MN 55344
  • Source
    USFDA