Recall Class: Class I
Date Recall Initiated: May 28, 2014
Product: HydroFinity Hydrophilic Guidewire; Nitinol Guidewire with Hydrophilic Coating
Recalled Model Numbers
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.
Nitinol Devices and Components, Inc. (NDC)
47533 Westinghouse Drive
Fremont, California 94539-7463
15 Hampshire Street
Mansfield, MA 02048
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The outer polymer jacket to the core wire may be damaged or torn during use, such as when the guidewire is withdrawn quickly through certain delivery catheters.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 firstname.lastname@example.org.
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.