Events

Recall of Device Recall FiberOptix Ultra 8 IAB

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International, Inc., Division of Teleflex 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
    73266
  • Event Risk Class
    Class 1
  • Event Number
    Z-1055-2016
  • Event Initiated Date
    2016-02-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143671
  • 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
    The sheath body may become separated from the sheath hub. if the separation occurs, there is a potential for bleeding from the device.
  • Action
    The firm, Teleflex Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 2/11/2016 via FedEx to its Customers. The letter described the product, problem and actions to be taken. The customers were informed of the reason for recall and were instructed to take the following actions: 1. If you have any products referenced in the attached enclosure, immediately discontinue use and quarantine those products appropriately. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall FiberOptix Ultra 8 IAB
  • Model / Serial
    Batch: 18F14A0031 18F14A0032 18F14A0033 18F14D0066 18F14E0018 18F14E0072 18F14F0067 18F14F0079 18F14G0045 18F14G0046 18F14G0081 18F14H0037 18F14J0023 18F14L0014 18F14M0033 18F15A0010 18F15B0015 18F15C0004 18F15C0023 18F15D0025 18F15D0052 18F15E0020 18F15F0002 18F15F0039 18F15G0005 18F15G0015 18F15H0006 18F15H0037 18F15H0051 18F15J0026 18F15L0007 18S14G0046
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Bahamas, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, Korea (Republic of [South] Korea), Myanmar, Mexico, Malaysia, Nepal, New Zealand, Panama, Peru, Philippines, Pakistan, Singapore, Thailand, Trinidad and Tobago, Taiwan, Uruguay, Viet Nam, and South Africa (Zuid Afrika).
  • Product Description
    FiberOptix Ultra 8 IAB: 8Fr 30cc || The Arrow¿ IAB is utilized for intraaortic balloon counterpulsation 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
    Arrow International, Inc., Division of Teleflex Medical Inc.

Manufacturer

Arrow International, Inc., Division of Teleflex Medical Inc.
  • Manufacturer Address
    Arrow International, Inc., Division of Teleflex Medical Inc., 9 Plymouth St, Everett MA 02149-1814
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA