FDAnews Device Daily Bulletin

BOSTON SCIENTIFIC ANNOUNCES WORLDWIDE DEVICE RECALL

Dec. 6, 2005
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Boston Scientific is proposing a worldwide recall of a type of heart filter because of concerns that the device will detach during implantation, possibly leading to cardiac or pulmonary embolization, resulting in serious injury or death.

The voluntary recall involves all Stainless Steel Greenfield Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. The total number of devices involved in the recall is estimated at 18,000.

The company is initiating the recall because of reports of detachment at the bond between the carrier capsule and the outer sheath of the filter's delivery system during the implant procedure. If the carrier capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization. Potential adverse events include serious patient injury or death.

The company initiated this recall after a review of complaint records and analysis of returned devices revealed the potential problem. A total of eight complaints were received, of which two were reported as involving serious patient injury requiring intervention and one was reported as a death.

A vena cava filter is a small cone-shaped device that is implanted in the inferior vena cava, the large vein that carries blood from the lower part of the body to the heart. The filter prevents pulmonary embolism by capturing blood clots before they can be carried to the lungs. The blood clots are trapped in the filter while blood flows both through and around the entrapped clot, allowing the clot to dissolve naturally.