According to Nitinol Devices & Components, damage to the jacket can result in embolization of polymer, potentially leading to vessel occlusion or damage. Until now, two cases have been reported where the polymer jacket separated from the device and embolized.
Developed by Nitinol Devices & Components, HydroFinity guidewire is a nitinol-core, polymer-jacketed guidewire with a hydrophilic coating intended for use in catheter placement and other procedures to treat vascular diseases. The guidewire is distributed by Covidien.
NDC and Covidien have taken the necessary steps to prevent future shipments of the recalled products. Covidien is recalling all product and NDC has notified regulatory agencies in the countries where the HydroFinity guidewire is distributed.
