Boston Scientific has announced the voluntary recall of two devices. The company revealed it was recalling the Flextome Cutting Balloon Device Monorail Delivery System/Peripheral Cutting Balloon Microsurgical Dilatation Device Small Monorail Delivery System and the Stainless Steel Greenfield Vena Cava Filters with 12Fr Femoral Introducer Systems.
The Cutting Balloon Device consists of an angioplasty balloon with microsurgical blades, called atherotomes, mounted to the balloon surface. As the balloon is expanded, the atherotomes score the lesions with incisions, allowing the balloon to dilate the vessel with less pressure. It is being realled as the company has determined through complaints and testing that the distal shaft of the Flextome catheter may separate during withdrawal of the device. A shaft separation may prolong the procedure or require additional surgery. The company has received a total of eight complaints involving patients, of which three required surgery. Boston estimates that the total number of devices affected by this recall is 40,000.
The Flextome Cutting Balloon Device Monorail Delivery System/Peripheral Cutting Balloon Microsurgical Dilatation Device Small Monorail Delivery System generated revenues of approximately $13 million year so far in 2005.
In addition, the company is voluntarily recalling all Stainless Steel Greenfield Vena Cava Filters with 12Fr Femoral Introducer Systems, manufactured before 10th March 2004 with a use by date of March 2007. The estimated 18,000 filters are being recalled because of a risk that the cone-shaped carrier capsule could become detached from the outer sheath of the delivery system during implantation. This could lead to cardiac and pulmonary embolization, resulting in patient injury and even death.
The company is acting on complaints received and its own analysis of returned devices. A total of eight complaints have so far been recorded of which two involved serious patient injury and one reported as a death.
Boston is working with the FDA to notify all countries of the recalls.
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