Events

Recall of Device Recall Concentric 7F Balloon Guide 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
    51401
  • Event Risk Class
    Class 2
  • Event Number
    Z-0899-2011
  • Event Initiated Date
    2009-02-27
  • Event Date Posted
    2011-01-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80199
  • 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, ventricular, general &, pastic surgery - Product Code GBS
  • Reason
    Product malfunction-- hub may leak at connection to the shaft due to insufficient adhesive curing.
  • Action
    Concentric Medical products sent an URGENT VOLUNTARY MEDICAL DEVICE REMOVAL letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and identify any affected product. Quarantine the product and call Concentric Medical Customer Service at 877-471-0076 (USA toll-free) or 650-938-2100 to receive instructions for returning the devices. For questions regarding this recall call 877-471-0076.

Device

Device Recall Concentric 7F Balloon Guide Catheter
  • Model / Serial
    Lot numbers 33367 and 33407
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland
  • Product Description
    Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA || Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.
  • 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