Nipro Medical Corporation: Medical Device Recall in 2012 - (Recall #: Z-0135-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 27, 2012

Date Posted: October 31, 2012

Recall Number: Z-0135-2013

Event ID: 63302

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.

Status: Terminated

Product Quantity: 1500

Code Information:

Item Code: AL+60000103 Lot #: 11E27, 11F27, 11H22, 11I19, 11J24, 12B03, 12B09, 12D09

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.

Voluntary or Mandated:

Voluntary: Firm initiated