Events

Recall of Device Recall 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
    70896
  • Event Risk Class
    Class 2
  • Event Number
    Z-1442-2015
  • Event Initiated Date
    2015-03-30
  • Event Date Posted
    2015-04-13
  • 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=135430
  • 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
    Baylis medical company is recalling two lots of protrack microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.
  • Action
    A recall notification, marked "URGENT" will be sent by Baylis Medical via overnight courier to all customers affected by the recall with a fax-back form. The form is to be faxed back to Baylis Medical confirming receipt of the recall notice. As per instructions on the fax-back form, affected devices are requested to be returned. Baylis Medical will replace the returned affacted catheters with a new catheter.

Device

Device Recall ProTrack Microcatheter
  • Model / Serial
    Lots CIFA180814 and CIFA080914
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR
  • Product Description
    ProTrack Microcatheter; || Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
  • 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