Events

Recall of Device Recall Ev3, Inc. (Medtronic)

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by ev3, 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
    73706
  • Event Risk Class
    Class 2
  • Event Number
    Z-1552-2016
  • Event Initiated Date
    2016-03-29
  • Event Date Posted
    2016-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144786
  • 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, angioplasty, peripheral, transluminal - Product Code LIT
  • Reason
    Medtronic is conducting a voluntary urgent medical device recall of two lots of the powercross 0.018" ¿ over the wire (otw) percutaneous transluminal angioplasty (pta) dilatation catheter because the product is mislabeled.
  • Action
    Consignees were sent on 3/29/2016 a Medtronic "Urgent Medical Device Recall" letter dated March 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall.

Device

Device Recall Ev3, Inc. (Medtronic)
  • Model / Serial
    A213373 and A216702
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
  • Product Description
    ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
  • Manufacturer
    ev3, Inc.

Manufacturer

ev3, Inc.
  • Manufacturer Address
    ev3, Inc., 3033 Campus Drive, Minneapolis MN 55441
  • 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