Events

Recall of Device Recall FlowGate 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
    63938
  • Event Risk Class
    Class 2
  • Event Number
    Z-0655-2013
  • Event Initiated Date
    2012-12-20
  • Event Date Posted
    2013-01-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115074
  • 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
    Firm received complaints of resistance and possible collapse of the distal tip of the flowgate balloon guide catheters during use for aspiration.
  • Action
    Concentric Medical sent a Urgent Medical Device Recall Notification letter dated December 19, 2012, to all affected customers. The letter identified the product the problme and the action needed to be taken by the customer. Customers were instructed to follow these instructions. 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Concentric Medical (Stryker Neurovascular) if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Concentric Medical (Stryker Neurovascular) can inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: Fax it to: 650-237-5230 Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices. 5. Keep a copy of the completed, signed Customer Response Form for your records. Upon receipt of the returned customer response form, a Stryker Representative will contact you to arrange for credit of returned devices. On behalf of Stryker Neurovascular, we sincerely thank you for your help and support and regret any inconvenience and appreciate your assistance in completing this recall. Should you have any questions concerning this matter please do not hesitate to contact the undersigned.

Device

Device Recall FlowGate Balloon Guide Catheter;
  • Model / Serial
    Catalog number 90253, lot # 36140; Catalog number 90254, lot numbers 36009, 36135.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (nationwide) including the states of CA, FL, GA, OR and TN.
  • Product Description
    FlowGate Balloon Guide Catheter; || Manufactured by Concentric Medical, Mountain View, CA. || FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are 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. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
  • 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