Boston Scientific Announces Worldwide Recall of Stainless Steel Greenfield® Vena Cava Filters Manufactured Before March 10, 2004

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. This recall does not affect vena cava filters that have been implanted in patients.

This recall includes only the Stainless Steel Greenfield® Vena Cava Filter with 12Fr Femoral Introducer Systems manufactured prior to March 10, 2004. All unused devices with a “use before date” prior to March 2007 are to be returned to Boston Scientific. The total number of devices involved in this recall is estimated at 18,000.

The Company is initiating this 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.

For more information on this update, please read the following link:

http://www.fda.gov/oc/po/firmrecalls/bostonsci12_05.html

If you have comments regarding this update, please email us at info@mdiconsultants.com.

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