Arrow International, Inc., Division of Teleflex Medical Inc.: Medical Device Recall in 2016 - (Recall #: Z-1061-2016)

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:

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.

Product Classification:

Class I

Date Initiated: February 10, 2016

Date Posted: March 16, 2016

Recall Number: Z-1061-2016

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:18F14A0041 18F14C0003 18F14C0006 18F14C0021 18F14C0026 18F14C0027 18F14C0028 18F14E0039 18F14E0055 18F14E0058 18F14F0035 18F14F0038 18F14F0054 18F14G0057 18F14G0077 18F14H0011 18F15B0023 18F15C0001 18F15C0008 18F15C0026 18F15D0028 18F15F0027 18F15F0037 18F15G0003 18F15G0011 18F15G0032 18F15H0046 18F15M0009

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