Arrow International, Inc., Division of Teleflex Medical Inc.: Medical Device Recall in 2016 - (Recall #: Z-1059-2016)

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:

UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-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-1059-2016

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: 18F13M0016 18F14A0017 18F14A0018 18F14A0022 18F14A0046 18F14E0054 18F14E0070 18F14G0038 18F14G0078 18F14H0007 18F14J0007 18F14J0025 18F14K0016 18F15A0035 18F15B0006 18F15B0014 18F15C0019 18F15E0028 18F15F0016 18F15G0007 18F15H0009 18F15H0035

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