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FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for i...

FDA Device Recall #Z-1057-2016 — Class I — February 10, 2016

Recall Summary

Recall Number Z-1057-2016
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

FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS 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: 18F14A0025 18F14A0026 18F14A0030 18F14A0049 18F14A0050 18F14A0051 18F14A0054 18F14A0057 18F14A0066 18F14A0067 18F14D0045 18F14E0004 18F14E0006 18F14E0016 18F14E0017 18F14E0052 18F14F0017 18F14F0047 18F14F0049 18F14F0080 18F14G0003 18F14G0004 18F14G0021 18F14G0037 18F14G0055 18F14G0056 18F14G0068 18F14G0070 18F14G0071 18F14G0076 18F14H0009 18F14H0030 18F14H0054 18F14H0055 18F14H0060 18F14H0061 18F14J0003 18F14J0005 18F14J0037 18F14K0006 18F14M0001 18F14M0014 18F14M0032 18F15A0005 18F15A0011 18F15A0026 18F15A0034 18F15B0005 18F15B0008 18F15B0010 18F15B0018 18F15B0020 18F15B0027 18F15C0002 18F15C0007 18F15C0010 18F15C0015 18F15C0024 18F15C0030 18F15C0036 18F15D0017 18F15D0032 18F15D0034 18F15D0043 18F15D0049 18F15E0003 18F15E0011 18F15E0014 18F15E0023 18F15E0029 18F15E0037 18F15F0011 18F15F0017 18F15F0021 18F15F0032 18F15G0001 18F15G0013 18F15G0021 18F15G0028 18F15G0034 18F15H0010 18F15H0015 18F15H0021 18F15H0024 18F15H0033 18F15J0013 18F15J0028 18F15J0038 18F15J0044 18F15J0049 18F15K0001 18F15K0007 18F15L0002 18S14G0068 18S14M0001 18S15C0002

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-1061-2016 Class I RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730... Feb 10, 2016
Z-1059-2016 Class I UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06... 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.

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