Devices

Device Recall UltraFlex IAB

  • Model / Serial
    Batch: 18F13M0016 18F14A0017 18F14A0018 18F14A0022 18F14A0046 18F14E0054 18F14E0070 18F14G0038 18F14G0078 18F14H0007 18F14J0007 18F14J0025 18F14K0016 18F15A0035 18F15B0006 18F15B0014 18F15C0019 18F15E0028 18F15F0016 18F15G0007 18F15H0009 18F15H0035
  • 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 30cc; Product Code: IAB-06830-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.
  • 1 Event

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

One device with a similar name

Learn more about the data here

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.