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Nitinol Devices and Components, Inc. recalls HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophili
Recalled July 2, 2014 · FDA recall Z-1816-2014 · Nitinol Devices and Components
Hazard
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire. · FDA Class I
Units
8485 in US, 9595 - ROW - total, all models
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
Description
Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.
Product
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 180 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.
Manufacturer(s)
Nitinol Devices and Components, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →