Home / Recalls / Arrow International, Inc., Division of Teleflex Medical Inc. / Z-1063-2016

Z-1063-2016 Class I Terminated

Recalled by Arrow International, Inc., Division of Teleflex Medical Inc. — Everett, MA

FDA device recall Z-1063-2016 was initiated by Arrow International, Inc., Division of Teleflex Medical Inc. on February 10, 2016 and is designated Class I. 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. The recall status is terminated (terminated May 12, 2021). Affected quantity: 13,405 US and 33,735 OUS in total.

Recall Details

Product Type: Devices
Report Date: March 16, 2016
Initiation Date: February 10, 2016
Termination Date: May 12, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 13,405 US and 33,735 OUS in total

Product Description

Percutaneous Insertion Tray; Product Code: IAK-S7IT 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.

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.

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).

Code Information

Batch: 18F14A0037 18F14B0040 18F14E0027 18F14F0027 18F14F0028

Other recalls by Arrow International, Inc., Division of Teleflex Medical Inc.

Z-1055-2016 Class I — FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic (February 10, 2016)
Z-1057-2016 Class I — FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB (February 10, 2016)
Z-1062-2016 Class I — Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utiliz (February 10, 2016)
Z-1058-2016 Class I — Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized f (February 10, 2016)
Z-1056-2016 Class I — Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized f (February 10, 2016)
Z-1060-2016 Class I — UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utiliz (February 10, 2016)
Z-1061-2016 Class I — RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized f (February 10, 2016)
Z-1059-2016 Class I — UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utiliz (February 10, 2016)