Events

Recall of Medtronic

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic 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
    30016
  • Event Risk Class
    Class 2
  • Event Number
    Z-1489-04
  • Event Initiated Date
    2004-09-15
  • Event Date Posted
    2004-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35015
  • 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
    Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Reason
    Spiral tip from dlp vad cannula may be loose and potentially detach during use.
  • Action
    A notification letter dated September 23, 2004 was sent by certified mail to US customers. The letter cautions the customer about the possibility of tip detachment and requests the impacted product to be returned to Medtronic for replacement. Customers are requested to complete a Field Corrective Action Certificate acknowledging the receipt of this information.

Device

Medtronic
  • Model / Serial
    Lot numbers 2003080199, 2003090147, 2003100101, 2004010371, and 2004030070.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide throughout the United States and worldwide.
  • Product Description
    Medtronic DLP VAD Venous Cannula for Ventricular Assist, Models 95036 and CB95036.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Manufacturer Address
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA