Devices

Device Recall FiberOptix Ultra 8

  • Model / Serial
    Batch: 18F14A0025 18F14A0026 18F14A0030 18F14A0049 18F14A0050 18F14A0051 18F14A0054 18F14A0057 18F14A0066 18F14A0067 18F14D0045 18F14E0004 18F14E0006 18F14E0016 18F14E0017 18F14E0052 18F14F0017 18F14F0047 18F14F0049 18F14F0080 18F14G0003 18F14G0004 18F14G0021 18F14G0037 18F14G0055 18F14G0056 18F14G0068 18F14G0070 18F14G0071 18F14G0076 18F14H0009 18F14H0030 18F14H0054 18F14H0055 18F14H0060 18F14H0061 18F14J0003 18F14J0005 18F14J0037 18F14K0006 18F14M0001 18F14M0014 18F14M0032 18F15A0005 18F15A0011 18F15A0026 18F15A0034 18F15B0005 18F15B0008 18F15B0010 18F15B0018 18F15B0020 18F15B0027 18F15C0002 18F15C0007 18F15C0010 18F15C0015 18F15C0024 18F15C0030 18F15C0036 18F15D0017 18F15D0032 18F15D0034 18F15D0043 18F15D0049 18F15E0003 18F15E0011 18F15E0014 18F15E0023 18F15E0029 18F15E0037 18F15F0011 18F15F0017 18F15F0021 18F15F0032 18F15G0001 18F15G0013 18F15G0021 18F15G0028 18F15G0034 18F15H0010 18F15H0015 18F15H0021 18F15H0024 18F15H0033 18F15J0013 18F15J0028 18F15J0038 18F15J0044 18F15J0049 18F15K0001 18F15K0007 18F15L0002 18S14G0068 18S14M0001 18S15C0002
  • 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 40cc; Product Code: IAB-05840-LWS || 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 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.