RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic b...

FDA Device Recall #Z-1061-2016 — Class I — February 10, 2016

Recall Summary

Recall Number Z-1061-2016
Classification Class I — Serious risk
Date Initiated February 10, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Arrow International, Inc., Division of Teleflex Medical Inc.
Location Everett, MA
Product Type Devices
Quantity 13,405 US and 33,735 OUS in total

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.

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).

Lot / 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

Other Recalls from Arrow International, Inc., Division o...

Recall # Classification Product Date
Z-1062-2016 Class I Percutaneous Insertion Tray; Product Code: IAK-... Feb 10, 2016
Z-1058-2016 Class I Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-... Feb 10, 2016
Z-1056-2016 Class I Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-... Feb 10, 2016
Z-1059-2016 Class I UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06... Feb 10, 2016
Z-1055-2016 Class I FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ ... Feb 10, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.