Rare Production Issue May Prevent Use of Catheter; Customer Inventory will be Replaced

On July 1, 2010, Spectranetics Corporation initiated a voluntary recall of specific lots of its thrombus extraction catheter (product number 60090-01) manufactured by the company since October 2009.

Customers who have received the affected lots of product will receive a letter from Spectranetics with requested actions and product replacement instructions. A manufacturing process improvement to correct the issue has been implemented and the product is available for shipment.

The company says the occurrence of this issue is very low and may result in a blocked guidewire lumen that restricts the loading of the thrombus extraction catheter onto the guidewire prior to insertion of the catheter into the patient. Spectranetics also says that no adverse events have been reported to the company.

For more information on the recall, visit the Spectranetics website.