CLASS II Device recall · Reported 31 Oct 2012 · FDA Enforcement Report

AquaLiner Hydrophilic Guidewire 0.035", Straight/ Regular recalled

Nipro Medical is recalling AquaLiner Hydrophilic Guidewire 0.035", Straight/ Regular, distributed in New York. The recall was initiated on 27 Jul 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem Code: AL+60000203 Lot #: 11G02

Quantity recalled100

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0136-2013
FDA event ID: 63302
Recalling firm: Nipro Medical, Miami, FL
Classification: Class II
Status: Terminated
Recall initiated: 27 Jul 2012
FDA classified: 25 Oct 2012
Reported: 31 Oct 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

27 Jul 2012	Recall initiated by company
25 Oct 2012	Classified by FDA	+90 days
31 Oct 2012	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

New York

Questions about this recall

Why was it recalled?

Which lots are affected?

Item Code: AL+60000203 Lot #: 11G02

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 63302

This product is part of a recall event; the main page for the event is AquaLiner Hydrophilic Guidewire 0.035", Straight/ Stiff recalled.

Reported	Class	Recall	Company	Reason	Where
31 Oct 2012	CLASS II	AquaLiner Hydrophilic Guidewire 0.035", Straight/ Stiff recalled	Nipro Medical	Other	NY
31 Oct 2012	CLASS II	AquaLiner Hydrophilic Guidewire 0.035", Angle/ Stiff recalled	Nipro Medical	Other	NY
31 Oct 2012	CLASS II	AquaLiner Hydrophilic Guidewire 0.035", Angle / Regular recalled	Nipro Medical	Other	NY
31 Oct 2012	CLASS II	AquaLiner Hydrophilic Guidewire 0.035", Angle/ Regular recalled	Nipro Medical	Other	NY

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