Events

Recall of Device Recall UltraFlex 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-1060-2016
  • 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=143677
  • 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 UltraFlex IAB
  • Model / Serial
    Batch:18F13M0017 18F13M0019 18F13M0021 18F14A0012 18F14A0013 18F14A0015 18F14A0016 18F14A0044 18F14A0047 18F14B0042 18F14B0043 18F14D0068 18F14E0005 18F14E0007 18F14E0031 18F14E0053 18F14E0069 18F14F0030 18F14F0031 18F14F0066 18F14G0020 18F14G0039 18F14G0066 18F14H0003 18F14H0010 18F14H0023 18F14H0024 18F14H0056 18F14J0006 18F14J0016 18F14J0027 18F14J0051 18F15A0008 18F15A0015 18F15A0023 18F15B0003 18F15B0007 18F15B0021 18F15C0006 18F15C0011 18F15C0027 18F15D0010 18F15D0019 18F15D0045 18F15E0002 18F15E0012 18F15F0008 18F15F0028 18F15F0038 18F15F0041 18F15G0016 18F15G0027 18F15H0005 18F15H0020 18F15H0032 18F15H0041 18F15J0007 18F15J0010 18F15J0021 18F15J0029 18F15J0039 18F15J0056 18F15K0016 18F15K0032 18F15L0001 18F15L0010
  • 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
    UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U || 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