Arrow International, Inc., Division of Teleflex Medical Inc. recalls RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation

Recalled March 16, 2016 · FDA recall Z-1061-2016 · Arrow International, Inc., Division of Teleflex Medical

Hazard

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device. · FDA Class I

Units

13,405 US and 33,735 OUS in total

Sold at

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).

Description

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Product

RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C 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.

Manufacturer(s)

Arrow International, Inc., Division of Teleflex Medical Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →