Events

Recall of Medrad Veris IBP Interface Cables

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
    36596
  • Event Risk Class
    Class 2
  • Event Number
    Z-0259-2007
  • Event Date Posted
    2006-12-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48970
  • 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
    Interface cables - Product Code MWI
  • Reason
    Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. in certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings.
  • Action
    The recalling firm contacted all affected customers via telephone or letter dated November 20, 2006 to inform them of the problem and instruct them to return the cables or apply corrective labeling.

Device

Medrad Veris IBP Interface Cables
  • Model / Serial
    Catalog number 3010478
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- including USA state of CA, CO, HI, IL, IN, MA, MD, NJ, NY, OH, PA, TX, and WA and countries of The Netherlands, Denmark, Australia, Brazil, Italy, and Japan.
  • Product Description
    Veris Invasive Blood Pressure Interface Cables-Part # 3010478. The product is an accessory to patient physiological monitor.
  • Manufacturer
    Medrad Inc

Manufacturer

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