Home / Recalls / Nitinol Devices and Components, Inc. / Z-1817-2014

Z-1817-2014 Class I Terminated

Recalled by Nitinol Devices and Components, Inc. — Fremont, CA

Recall Details

Product Type
Devices
Report Date
July 2, 2014
Initiation Date
May 28, 2014
Termination Date
January 13, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8485 in US, 9595 - ROW - total, all models

Product Description

HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 260 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.

Reason for Recall

Reports of outer polymer jacket to the core wire being damaged during use on the HydroFinity Guidewire.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.

Code Information

Model HPRS35260- all lots.

Other recalls by Nitinol Devices and Components, Inc.

  • Z-1818-2014 Class I — HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, S (May 28, 2014)
  • Z-1820-2014 Class I — HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, St (May 28, 2014)
  • Z-1823-2014 Class I — HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, S (May 28, 2014)
  • Z-1813-2014 Class I — HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, S (May 28, 2014)
  • Z-1821-2014 Class I — HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, S (May 28, 2014)
  • Z-1815-2014 Class I — HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, S (May 28, 2014)
  • Z-1816-2014 Class I — HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, S (May 28, 2014)
  • Z-1814-2014 Class I — HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, S (May 28, 2014)
  • Z-1822-2014 Class I — HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM (May 28, 2014)
  • Z-1819-2014 Class I — HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, St (May 28, 2014)