Nitinol Devices & Components, Inc. (NDC) recalled its HydroFinity Hydrophilic Guidewires. The HydroFinity Guidewire was developed and manufactured by NDC and distributed by Covidien. 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.
The guidewires were recalled due to two reports of the outer polymer jacket to the core wire being damaged when the guidewire was withdrawn rapidly through certain delivery catheters, and ten cases where the product was less severely damaged during use.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.
The HydroFinity Guidewire was distributed in the U.S., Belgium, Denmark, France, Germany, Italy, Norway, Sweden, UK and Canada.
See the Recall
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