Boston Scientific Announces Worldwide Recall of Stainless Steel Greenfield® Vena Cava Filters Manufactured Before March 10, 2004Dec 5, 2005 | www.fda.gov
Boston Scientific Corporation (NYSE: BSX) today 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 product code for these devices under recall is M001505010. The product code and the use before date of the device are located on the box and pouch label. 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.
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.
The products affected by this recall were distributed to hospitals worldwide. Boston Scientific is notifying affected hospitals through detailed recall notification letters, including instructions on how to return recalled product.
The Company is working with the U.S. Food and Drug Administration (FDA) and is notifying officials in other countries of this recall.
Inquires may be directed to Boston Scientific at 888-272-1001.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.