Spectranetics Corporation has begun a 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 product will receive a letter from Spectranetics explaining product replacement instructions. A manufacturing process improvement to correct the issue has been implemented and is available for shipment.
Although occurrence of this issue is very low, it 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. While Spectranetics has received and confirmed customer complaints on this issue, no adverse events have yet been reported.
“We are committed to delivering high-quality devices to our customers and their patients. We will endeavour 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.
The company estimates replacement costs in the range of US$250,000 to US$400,000 in the quarter leading up to the end of June.
The Food and Drug Administration has been informed of this action. For more information, visit http://www.spectranetics.com.