Spectranetics issues product recall

Springs-based medical device maker Spectranetics has launched a voluntary recall of specific lots of its thrombus extraction catheter, marking yet another chapter in the saga of the company’s troubles.

The catheter has been manufactured by Spectranetics since October, and the company said it has received and confirmed customer complaints.

The company said the problem lies in a blocked guidewire lumen that restricts loading the catheter onto the guidewire before it is inserted into the patients.

Officials said customers who have received the effective lots will receive a letter from Spectranetics with product replacement instructions. A new product is available for shipment.

Costs of the recall are estimated to be $250,000 to $400,000.

Spectranetics develops, manufactures and markets single-use medical devices used in minimally invasive procedures within the cardiovascular systems.

In June, Spectranetics agreed to pay $8.9 million to settle a pair of legal actions brought by stockholders against the company.

Last year, the company paid $5 million to resolve federal government charges that it illegally imported and marketed unapproved medical devices. The settlement came in December, after a raid by the Customs Department and the Department of Justice earlier in the fall.