Spectranetics commences voluntary recall and replacement of specific lots of thrombus extraction catheter

Jul 2 2010

Spectranetics Corporation (Nasdaq: SPNC) today initiated a voluntary recall of specific lots of its thrombus extraction catheter (product number 60090-01) manufactured by Spectranetics since October 2009. The Food and Drug Administration has been informed of this action and communication to various Competent Authorities outside of the United States has begun. While Spectranetics has received and confirmed customer complaints on this issue, no adverse events have been reported to the Company. 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 product is available for shipment.

“We are committed to deliver high-quality devices to our customers and their patients. We will endeavor to complete this voluntary action and the replacement of affected product in an expedient manner”

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.

The Company plans to replace all affected units and estimates costs in the range of $250,000 to $400,000, which will be recorded within cost of goods sold during the quarter ended June 30, 2010. The cost estimate includes replacement of customer inventory as well as the write-off of Spectranetics inventory impacted by this issue. Inventory of the thrombus extraction catheter is currently available and production volumes have been increased so that all customer demand and replacement product can be fulfilled over the next several weeks.

"We are committed to deliver high-quality devices to our customers and their patients. We will endeavor to complete this voluntary action and the replacement of affected product in an expedient manner," stated Emile J. Geisenheimer, Chairman, President and Chief Executive Officer.

SOURCE Spectranetics