Events

Recall of Device Recall Medtronic DxTerity(TM) Diagnostic Catheter

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
    79591
  • Event Risk Class
    Class 2
  • Event Number
    Z-1479-2018
  • Event Initiated Date
    2018-03-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162735
  • 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, intravascular, diagnostic - Product Code DQO
  • Reason
    Medtronic has determined that the french size indicator on the outer box may incorrectly reflect a 6 french size, rather than the correct 5 french size. the catheters inside the carton are the correct dxt5jl40 item, the inner pouch has all the correct labeling, and all the other information and configuration details are correct.
  • Action
    Medtronic initiated consignee communications on 13-Mar- 2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. OUS communications were sent per locally approved methods. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.

Device

Device Recall Medtronic DxTerity(TM) Diagnostic Catheter
  • Model / Serial
    UDI 20643169689309, Lot Number 60074805
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
  • Product Description
    Medtronic DxTerity(TM) Diagnostic Catheter, JL 4.0, 6F, REF DXT5JL40
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • Manufacturer Address
    Medtronic Vascular, 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • 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