Fremont, Calif.-based Nitinol Devices & Components Inc. (NDC) has issued a voluntary recall of its HydroFinity Hydrophilic Guidewires. The HydroFinity Guidewire is developed and manufactured by NDC and distributed by Covidien plc. It is a nitinol-core, polymer-jacketed guidewire with a hydrophilic coating intended for use in catheter placement and other procedures to treat vascular diseases.
NDC is conducting this recall due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters and ten cases where the product was less severely damaged during use. 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.
NDC and Covidien have taken the necessary steps to prevent future shipments of the recalled products. Covidien alerted customers by letter on June 3 and is recalling all product. Unused product should be returned to Covidien. Additionally, NDC has notified regulatory agencies in the countries where the HydroFinity Guidewire is distributed: United States, Belgium, Denmark, France, Germany, Italy, Norway, Sweden, the United Kingdom and Canada.
According to NDC officials, the company has apprised the U.S. Food and Drug Administration of its action.
NDC is a contract manufacturer of nitinol-based medical devices.