HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 ...
FDA Device Recall #Z-1818-2014 — Class I — May 28, 2014
Recall Summary
| Recall Number | Z-1818-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | May 28, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Nitinol Devices and Components, Inc. |
| Location | Fremont, CA |
| Product Type | Devices |
| Quantity | 8485 in US, 9595 - ROW - total, all models |
Product Description
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length; Manufactured for Covidien, Plymouth, MN; Manufactured by: NDC Inc., Fremont, CA Manufactured in Costa Rica The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
Reason for Recall
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
Lot / Code Information
Model HPSA35150- all lots.
Other Recalls from Nitinol Devices and Components, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1815-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guid... | May 28, 2014 |
| Z-1822-2014 | Class I | HydroFinity Hydrophilic guidewire; 0.035 OD, ... | May 28, 2014 |
| Z-1816-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guid... | May 28, 2014 |
| Z-1813-2014 | Class I | HydroFinity Hydrophilic guidewire; Nitinol Guid... | May 28, 2014 |
| Z-1819-2014 | Class I | HydroFinity Hydrophilic guidewire;Nitinol Guide... | May 28, 2014 |
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.