HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 ...

FDA Device Recall #Z-1815-2014 — Class I — May 28, 2014

Recall Summary

Recall Number Z-1815-2014
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, Standard Shaft, Straight 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 HPRS35150- all lots.

Other Recalls from Nitinol Devices and Components, Inc.

Recall # Classification Product Date
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-1818-2014 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.