> ## Content Index > Fetch the complete content index at: https://www.foodconsumer.org/llms.txt > Use this file to discover other available public pages before exploring further. # Nitinol Devices and Components, Inc., HydroFinity Hydrophilic Guidewire - May be Damaged during Use and May Lead to Injury - URL: https://www.foodconsumer.org/nitinol_devices_and_components_0625141241/ - Published: 2014-06-25T13:40:00.000Z - Updated: 2026-09-22T16:29:29.000Z - Description: Nitinol Devices and Components is recalling all lots of its HydroFinity Hydrophilic Guidewire because the polymer jacket can tear during use and embolize, potentially blocking blood vessels. The firm received 12 malfunction reports including two injuries, one needing surgery. - Author: Food Consumer - Tags: Miscellaneous, Health News, #vivvo-import Recall Class: Class I Date Recall Initiated: May 28, 2014 Product: HydroFinity Hydrophilic Guidewire; Nitinol Guidewire with Hydrophilic Coating Recalled Model Numbers HPRA35150 HPRA35180 HPRA35260 HPRS35150 HPRS35180 HPRS35260 HPSA35150 HPSA35180 HPSA35260 HPSS35150 HPSS35180 HPSS35260 All HydroFinity Hydrophilic Guidewire lots are affected by this recall. The affected devices were manufactured from November 2013 through May 2014 and distributed from November 30, 2013 through May 14, 2014. Use: The HydroFinity Hydrophilic Guidewire is a steerable, nitinol-core, polymer-jacketed guidewire with a hydrophilic coating. It is used to place catheters and other diagnostic devices during invasive medical procedures. The HydroFinity Hydrophilic Guidewire is used in hospitals and other healthcare facilities. Recalling Firm: Nitinol Devices and Components, Inc. (NDC) 47533 Westinghouse Drive Fremont, California 94539-7463 Distributor: Covidien 15 Hampshire Street Mansfield, MA 02048 508-261-8000 Reason for Recall: The outer polymer jacket to the core wire may be damaged or torn during use, such as when the guidewire is withdrawn quickly through certain delivery catheters. Damage to the jacket can result in reduced or blocked blood flow (embolization) by torn polymer, potentially leading to blood vessel blockage (occlusion) or damage. Surgical intervention may be necessary to resolve blockages in the blood vessels. NDC received 12 reports, including 2 injuries, where the device malfunctioned. Two cases were reported where the polymer jacket separated from the device and embolized. One case required surgical intervention. The use of this affected product may cause serious adverse health consequences, including death. Public Contact: For information or to report a problem, contact NDC Customer Service at 1-510-683-2000, Monday through Friday, between the hours of 8:00 am and 5: 00 pm Pacific Time or email quality@nitinol.com. FDA District: San Francisco District Office More Information about this Recall: Covidien sent an Urgent Product Recall letter dated May 30, 2014 to their customers. The letter identified the product, problem, and actions to be taken by the customers. There is no action necessary if the product has been used. For products that have not been used: Stop using the recalled devices. Remove and separate these devices from other inventory. Complete the reply (verification) form enclosed with the letter even if you don’t have these devices in your inventory. Return the unused devices to Covidien. About Class I Recalls Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.