Recall of Boston Scientific Vena Cava Filters (Feb. 2006)

Boston Scientific is recalling certain vena cava filter systems. The recalled devices are small cone-shaped filters used to help prevent pulmonary embolism. The filters are implanted in the inferior vena cava to capture blood clots before they're carried to the lungs.

The devices are being recalled because in a small number of cases, a certain
part of the filter's delivery system has become detached while the device was being implanted. This has led to reports of patient injuries and one patient death. This recall applies only to devices that have not yet been implanted in patients.

The recall affects the Stainless Steel Greenfield® Vena Cava Filters with 12Fr Femoral Introducer Systems manufactured before March 10, 2004. These devices have a "use before" date of March 2007. For instructions on how to return any unused devices covered by this recall, contact Boston Scientific at 888-272-1001.

Additional Information:

Recall -- Firm Press Release.
http://www.fda.gov/oc/po/firmrecalls/bostonsci12_05.html

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News & Politics

Tags:

• Boston
• Scientific
• Vena
• Cava
• Filters
• Recall
• FDA
• Pulmonary
• Embolism
• Patient
• Safety