FDA-Device2016-03-16Class I
FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic 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.
Arrow International, Inc., Division of Teleflex Medical Inc.
Hazard
The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
Sold states
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).
Affected count
13,405 US and 33,735 OUS in total
Manufactured in
9 Plymouth St, N/A, Everett, MA, United States
Products
FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1057-2016Don't want to check this manually?
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