Arrow International, Inc., Division of Teleflex Medical Inc.: Medical Device Recall in 2016 - (Recall #: Z-1058-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U 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.

Product Classification:

Class I

Date Initiated: February 10, 2016

Date Posted: March 16, 2016

Recall Number: Z-1058-2016

Event ID: 73266

Reason for Recall:

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

Status: Terminated

Product Quantity: 13,405 US and 33,735 OUS in total

Code Information:

Batch: 18F14B0044 18F14B0045 18F14E0060 18F14F0019 18F14G0067 18F14H0002 18F14J0026 18F15A0033 18F15B0009 18F15B0019 18F15C0012 18F15D0016 18F15D0037 18F15D0044 18F15F0001

Distribution Pattern:

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).

Voluntary or Mandated:

Voluntary: Firm initiated