Events

Recall of Medrad Mark 7 Arterion Injection System

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

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
    71994
  • Event Risk Class
    Class 2
  • Event Number
    Z-2775-2015
  • Event Initiated Date
    2015-08-04
  • Event Date Posted
    2015-09-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139674
  • 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
    Software version sw 005.006_sh, resulted in the removal of purge enforcement from traditional new-case, power up and syringe change use cases while the injector head is in the upright position.
  • Action
    Direct accounts were notified by UPS Notification letter dated August 4, 2015 and advised when using the Arterion Injection System to ensure that purges are completed to avoid the injection of air.

Device

Medrad Mark 7 Arterion Injection System
  • Model / Serial
    Catalog numbers: ART 700 PEDL, ART 700 TABL, ART 700 OCS, which utilize Software Version SW 005.006_SH.  Affected serial numbers: 20329, 20570, 101148, 20392, 20425, 20427, 30046, 100945, 100186, 21255, 30086, 20025, 101153, 101159, 20714, 100873, 20437, 100033, 100249, 20333, 100511, 101206, 100002, 100890, 101208, 20323, 20914, 20342, 10172, 10074, 20195, 20196, 20850, 20929, 101106, 30020, 30024, 30033, 20252, 10087, 20851, 100009, 100864, 100335, 10095, 20302, 20306, 100013, 20918, 100141, 20158, 100784, 20735, 20422, 101149, 20842, 20018, 101114, 100056, 100075, 20434, 21024, 20311, 20763, 10055, 20786, 20701, 20729, 20040, 100092, 20501
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution. US Nationwide, Germany, France, UK, Netherlands, Sweden, and Canada.
  • Product Description
    Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
  • Manufacturer
    Bayer Healthcare

Manufacturer

Bayer Healthcare
  • Manufacturer Address
    Bayer Healthcare, 1 Bayer Dr, Indianola PA 15051-9702
  • Manufacturer Parent Company (2017)
    Bayer AG
  • Source
    USFDA