Events

Recall of EverCross 0.035" OTW PTA Dilatation Catheter

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
    68034
  • Event Risk Class
    Class 2
  • Event Number
    Z-1489-2014
  • Event Initiated Date
    2014-04-09
  • Event Date Posted
    2014-04-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126834
  • 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, percutaneous - Product Code DQY
  • Reason
    Covidien is recalling 2 production lots of evercross 0.035 pta balloon catheter because of a product labeling error. there is a discrepancy in the pta balloon length and the delivery catheter length printed on the product labeling.
  • Action
    Consignees were sent a Covidien "Urgent Product Recall" letter dated April 09, 2014. The letter described the problem and the product involved in the recall. The letter described the required actions which included to immediately quarantine and discontinue use of the affected devices and to return affected product. Requested consignees to complete the Verification Form and return it to their Covidien Sales Representative. For questions they can contact Covidien Customer Service at 1-800-716-6000.

Device

EverCross 0.035" OTW PTA Dilatation Catheter
  • Model / Serial
    AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA.
  • Product Description
    ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
  • Manufacturer
    Ev3, Inc.

Manufacturer

Ev3, Inc.
  • Manufacturer Address
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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