Nitinol Devices & Components said Wednesday it is recalling all lots of its HydroFinity hydrophilic guidewires. Unused items should be returned to the product’s distributor, Covidien.

The companies notified customers of the recall in a June 3 letter and have taken steps to ensure that recalled products will not be shipped out, NDC said.

The nitinol-core, polymer-jacketed guidewire with hydrophilic coating is used to facilitate catheter placement and other procedures to treat vascular diseases, Fremont, Calif.-based NDC said. Damage to the jacket can cause the polymer to break up, leading to vessel occlusion or damage, possibly necessitating surgical intervention.

NDC received two reports of the device’s outer polymer jacket being damaged when the guidewire was withdrawn rapidly through delivery catheters. In one case, surgery was required. Ten cases of less serious damage also were reported.

The company has notified the FDA, Health Canada and regulatory authorities in eight European countries where HydroFinity guidewires are distributed.  Any adverse events or quality problems experienced with the product should be reported to the FDA’s MedWatch adverse event reporting program, NDC said. — Kellen Owings

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