Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic b...
FDA Device Recall #Z-1056-2016 — Class I — February 10, 2016
Recall Summary
| Recall Number | Z-1056-2016 |
| 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
Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-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.
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: 18F14A0031 18F14A0032 18F14A0033 18F14D0066 18F14E0018 18F14E0072 18F14F0067 18F14F0079 18F14G0045 18F14G0046 18F14G0081 18F14H0037 18F14J0023 18F14L0014 18F14M0033 18F15A0010 18F15B0015 18F15C0004 18F15C0023 18F15D0025 18F15D0052 18F15E0020 18F15F0002 18F15F0039 18F15G0005 18F15G0015 18F15H0006 18F15H0037 18F15H0051 18F15J0026 18F15L0007 18S14G0046
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-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 |
| 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.