Events

Recall of Device Recall Medtronic

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

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
    36845
  • Event Risk Class
    Class 2
  • Event Number
    Z-0208-2007
  • Event Initiated Date
    2006-11-01
  • Event Date Posted
    2006-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49447
  • 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
    vascular catheter - Product Code ITX
  • Reason
    Sterility may be compromised as evidenced by a loss of package integrity.
  • Action
    On 11/1/06, the firm issued letters via Federal Express to all its direct consignees, informing them of the affected product and providing instructions on the recall.

Device

Device Recall Medtronic
  • Model / Serial
    All Codes.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Switzerland, France, Belgium, Germany.
  • Product Description
    Pioneer Catheter (Crosspoint TransAccess Catheter); || Model TA-XP-001; Product is manufactured and distributed by Medtronic Vascular, Santa Rosa, CA 95403
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • Manufacturer Address
    Medtronic Vascular, 5345 Skylane Boulevard, Santa Rosa CA 95403-1044
  • Source
    USFDA