Boston Scientific Recalls RotaLink Device

Boston Scientific Corp. (Natick, MA) is voluntarily recalling its Rotablator RotaLink Advancer and RotaLink Plus rotational atherectomy systems. The company has determined that the brake on some advancers included in these systems may not adequately secure the guidewire as intended, making such units unsafe for use.

During the first half of 1999, sales of the recalled devices and related products amounted to approximately $60 million. The original Rotablator Rotational Atherectomy Device, which is the product currently sold in Japan, is not affected by this recall.

The recall is particularly bad news for Boston Scientific, since the company's Nir on Ranger with Sox stent was recalled last October due to a leakage in the balloon used to deploy the stent. For more information, see Boston Scientific to Cease Shipments of Faulty Stent Systems.