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Recall Observatory FDA recall evidence

Device product

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.

Z-0136-2013

July 27, 2012

Class II

Product summary

Firm
Nipro Medical Corporation
Event
Event 63302
Status
Terminated
Classification
Class II
Quantity
100
Official record key
device-enforcement:Z-0136-2013

Official wording

Reason: 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.

Code information: Item Code: AL+60000203 Lot #: 11G02

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.