AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewir...

FDA Device Recall #Z-0134-2013 — Class II — July 27, 2012

Recall Summary

Recall Number Z-0134-2013
Classification Class II — Moderate risk
Date Initiated July 27, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Nipro Medical Corporation
Location Miami, FL
Product Type Devices
Quantity 400

Product Description

AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.

Reason for Recall

Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.

Distribution Pattern

Worldwide Distribution-Distributed in the state of New York and the countries of Spain, Germany, Argentina, Panama, Mexico, Chile, Colombia, Ecuador, Peru, and Brazil.

Lot / Code Information

Item Code: AL+60000303 Lot #: 11I27, 12B13

Other Recalls from Nipro Medical Corporation

Recall # Classification Product Date
Z-0912-2026 Class II Hemodialysis System, Surdial DX REF: MC+SDX01 ... Oct 27, 2025
Z-1876-2018 Class II Nipro Blood Tubing set with Priming Set and Tra... Dec 19, 2017
Z-0161-2016 Class II Nipro Safe Touch TULIP Safety Fistula Needle, F... Aug 13, 2015
Z-0624-2016 Class II NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemod... Mar 30, 2015
Z-0599-2016 Class III NIPRO SafeTouch II Safety AVF Needle, 17G x 1 ... Apr 1, 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.