Nitinol Devices & Components is recalling guidewires after reports of problems during vascular procedures.
The Fremont, Calif.-based company said it received two reports that the outer polymer jacket of its HydroFinity Hydrophilic Guidewires became damaged when the guidewires were withdrawn rapidly through delivery catheters. It also received reports of 10 cases of less severe damage.
The nitinol-core, polymer-jacketed guidewire has a hydrophilic coating and is used for catheter placement and other procedures to treat vascular diseases. A damaged jacket may cause embolization of the polymer and possible occlusion. In two cases, the polymer jacket separated from the device and embolized and one case resulted in surgical intervention.
Covidien, which distributes the guidewires, alerted customers by letter. Unused guidewires should be returned to Covidien, and any adverse events should be reported to the FDA’s MedWatch program.