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U.S. Department of Health and Human Services

Safety

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Boston Scientific Stainless Steel Greenfield Vena Cava Filters

Audience: Cardiologists and other healthcare professionals

[UPDATE 01/13/2006] Recall classified as Class 1 recall by FDA.

[Posted 12/06/2005] Boston Scientific Corporation announced that it is voluntarily recalling all Stainless Steel Greenfield Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. All unused devices with a "use before date" prior to March 2007 are to be returned to Boston Scientific (product code M001505010). The total number of devices involved in this recall is estimated at 18,000. There have been 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. This recall does not affect vena cava filters that have been implanted in patients.

UPDATE: January 13, 2005 - Recall Notice - FDA

[December 02, 2005 - Press Release - Boston Scientific Corporation]