Recall of Device Recall Arrow International, Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    System, balloon, intra-aortic and control - Product Code DSP
  • Reason
    Outer package product label incorrectly identifies the product as fiberoptix flex iab 7.5fr rather than the correct fiberoptix iab 8fr.
  • Action
    Arrow International notified Users, Distributors, Risk Managers by letter dated February 5, 2015. The letter explains the labeling error and requests immediately discontinue use and quarantine product. Customers were instructed to complete the Recall Acknowledgement Form and return by fax to 1-855-419-8507 whether they have or do not have the affected product. Customers with questions were instructed to contact their local sales representataive or Customers Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.


  • Model / Serial
    Lot Number: 18F14M0001
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Belgium
  • Product Description
    ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr || Product Code: IAB-05840-LWS || The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
  • Manufacturer


  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Manufacturer Parent Company (2017)
  • Source