UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aort...
FDA Device Recall #Z-1059-2016 — Class I — February 10, 2016
Recall Summary
| Recall Number | Z-1059-2016 |
| 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
UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-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: 18F13M0016 18F14A0017 18F14A0018 18F14A0022 18F14A0046 18F14E0054 18F14E0070 18F14G0038 18F14G0078 18F14H0007 18F14J0007 18F14J0025 18F14K0016 18F15A0035 18F15B0006 18F15B0014 18F15C0019 18F15E0028 18F15F0016 18F15G0007 18F15H0009 18F15H0035
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-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.