Spectranetics has initiated a voluntary recall of specific lots of thrombus extraction catheter (product number 60090-01) manufactured since October 2009. The FDA has been informed that the action and communication to various competent authorities outside the US has begun.
Spectranetics said that customers who have received the affected lots of product will receive a letter with requested actions and product replacement instructions. A manufacturing process improvement to correct the issue has been implemented and product is available for shipment.
Spectranetics said that the occurrence of the 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 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.
The 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.
Emile Geisenheimer, chairman, president and CEO, said: “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.”