Events

Recall of ProTrack Microcatheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baylis Medical Corp *.

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
    72539
  • Event Risk Class
    Class 2
  • Event Number
    Z-0356-2016
  • Event Initiated Date
    2015-10-28
  • Event Date Posted
    2015-12-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=141478
  • 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
    Wire, guide, catheter - Product Code DQX
  • Reason
    Microcatheter may have circumferential defects (cracks) along its shaft.
  • Action
    Recall notification letter was sent to affected consignees on 10/28/2015 via courier. The letter contained a fax-back form to be completed by the consignee and sent to the quality department of the recalling firm.

Device

ProTrack Microcatheter
  • Model / Serial
    CIFA161013, CIFA131113, CIFA271113, CIFA311213, CIFA210214, CIFA070314, CIFA270314, CIFA070514, CIFA210514, CIFA100614, CIFA240614, CIFB100714, CIFA100714, CIFA180814, CIFA080914, CIFA241014, CIFA221014, CIFA050115, CIFA210115, CIFA060215
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
  • Manufacturer
    Baylis Medical Corp *

Manufacturer

Baylis Medical Corp *
  • Manufacturer Address
    Baylis Medical Corp *, 5959 TransCanada Highway, Montreal Canada
  • Manufacturer Parent Company (2017)
    Baylis Medical Company, Inc
  • Source
    USFDA