Spectranetics Corp. (SPNC: 5.21 0.00 0.00%) voluntarily recalled a specific lot of its thrombus extraction catheters due to complaints from the customers regarding certain manufacturing defects. The company has notified the same to the Food and Drug Administration (FDA) and to the other competent authorities outside the US.The manufacturing defect was such that it would have blocked the guidewire lumen, which in turn would have restricted the loading of the thrombus extraction catheter onto the guidewire before the insertion of the catheter into the patient.
Spectranetics has moved ahead with the fixing up of the manufacturing process. The shipment of the fixed product has also begun. The replacement of the affected product units, are likely to cost the company $0.25 million - $0.40 million. The corrective actions taken by Spectranetics reinforce our view that the company would maintain the revenue growth trend, going forward.
Spectranetics develops, manufactures, markets and distributes single-use medical devices used in minimally invasive procedures within the cardiovascular system. The company operates through two business units, Vascular Intervention and Lead Management, which recorded $15.5 million and $9.9 million, respectively, in the first quarter of fiscal 2010.
Through the Vascular Intervention business unit, the company markets aspiration and thrombectomy catheters for the removal of thrombus and support catheters to facilitate crossing of coronary and peripheral arterial blockages. The products are used to treat arterial blockages in the heart and legs as well as the removal of problematic pacemaker and defibrillator leads. In the first quarter of fiscal 2010, thrombectomy sales increased 7% year over year, due to higher sales in Europe.http://www.spectranetics.com/
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