June 18, 2014 — Nitinol Devices & Components (NDC) and Covidien have recalled HydroFinity Hydrophilic guidewires because the wire’s coating can break off, travel in a patient’s bloodstream, and cause serious complications that may require surgery.
UPDATE: June 20, 2014 — Read the recall notification from the U.S. Food and Drug Administration (FDA).
The guidewires are intended to help doctors place a catheter (long, flexible tube) inside a patient’s body for the treatment of vascular diseases, such as blood clots, artery blockages, aneurysms, and more. Each wire is designed with a core made of nitinol, a jacket made of polymer, and a hydrophilic (water-repellant) coating.
The manufacturer has received a dozen customer complaints. Two complaints occurred when the guidewire was rapidly withdrawn through certain delivery catheters, which damaged the outer polymer jacket to the core wire. Another 10 incidents involve less serious damage during use.
NDC issued the following warning:
“Damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. Vessel occlusion may necessitate surgical intervention to resolve. Two cases were reported where the polymer jacket separated from the device and embolized. One case required surgical intervention.”
The guidewires are distributed by Covidien, who notified customers of the recall on June 3 with a letter describing the problem. Covidien provided instructions on how to return the recalled guidewires. They have also notified regulatory agencies of countries where the guidewires are sold, including the U.S., Belgium, Denmark, France, Germany, Italy, Norway, Sweden, UK and Canada.
Do I have a Catheter Guidewire Lawsuit?
The Schmidt Firm, PLLC is currently accepting HydroFinity Hydrophilic guidewire induced injury cases in all 50 states. If you or somebody you know has been injured by a catheter guidewire, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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