Events

Recall of Distal Access Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Concentric Medical 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
    69764
  • Event Risk Class
    Class 2
  • Event Number
    Z-0525-2015
  • Event Date Posted
    2014-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-12-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131488
  • 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
    Distal access catheters were shipped to us customers with the directions for use that included instructions for aspiration. this version of the dfu is only approved outside of the us.
  • Action
    The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated September 26, 2013 consignees/customers at all affected sites by registered mail. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately locate the subject devices and quarantine them; distribute notice to all affected departments in your facility; inform Concentric Medical (Stryker Neuovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via Fax to: 1-866-876-4355 or email a copy to: NeuroComplaints@stryker.com, complete form even if you do not have any subject devices to return, and keep a copy of the completed, signed Customer Response Form for your records. Should you have any queries concerning this matter, please do not hesitate to contact the QA Manager at 650-810-1716.

Device

Distal Access Catheter
  • Model / Serial
    Lot Number 36007: 09-2014 Lot Number 35767: 05-2014 Lot Number 35980: 08-2014 Lot Number 35951: 08-2014 Lot Number 36050: 09-2014 Lot Number 36017: 09-2014 Lot Number 36029: 09-2014 Lot Number 35583: 02-2014
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to states of: TX, TN, PA, MI, VA, CA, NC, MS, FL, IL, MA, AZ, OK, NY, KY, WA, and AL.
  • Product Description
    Distal Access Catheter: || Model Numbers: 90121, 90130, 90131, 90160. || The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
  • Manufacturer
    Concentric Medical Inc

Manufacturer

Concentric Medical Inc
  • Manufacturer Address
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA