Events

Recall of Device Recall NC Trek RX Coronary Dilatation Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott 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
    76841
  • Event Risk Class
    Class 1
  • Event Number
    Z-2039-2017
  • Event Initiated Date
    2017-03-22
  • Event Date Posted
    2017-05-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154377
  • 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
    Catheters, transluminal coronary angioplasty, percutaneous - Product Code LOX
  • Reason
    Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
  • Action
    An Urgent Field Safety Notice dated 3/22/17 was sent to customers to inform them that Abbott Vascular is recalling the NC Trek RX Coronary Dilation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PCTA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. The letter informs the customers of how does the issue occur and what action is Abbott Vascular asking the customers to take. Customers with any questions are instructed to contact local Abbott Vascular Representative or Customer Service Department at (800) 227-9902. On 5/15/17, Abbott Vascular posted a press release on their website to inform customers that Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction.

Device

Device Recall NC Trek RX Coronary Dilatation Catheter
  • Model / Serial
    Lot Number 60202G1 60301G1 60502G1 60301G1 60401G1 61101G1 60202G1 60401G1 60601G1 60801G1 61101G1 60302G1 60401G1 60601G1 60801G1 60202G1 60401G1 60502G1 60601G1 60701G1 60902G1 61004G1 61101G1 60202G1 60301G1 60401G1 60502G1 60601G1 60701G1 60801G1 60902G1 61101G1 60401G1 60601G1 60801G1 60301G1 60701G1 60301G1 60502G1 60701G1 60301G1 60502G1 60701G1 60902G1 60301G1 60502G1 60701G1 61004G1 60301G1 60401G1 60601G1 60701G1 60805G1 61004G1 50204G1 50406G1 50202G1 50901G1 50204G1 60202G1 60502G1 60701G1 61101G1 60202G1 60506G1
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US and Worldwide
  • Product Description
    NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, || 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, || 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, || 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, || 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Manufacturer Address
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA