Class 1 Recall: Boston Scientific Stainless Steel Greenfield® Vena Cava Filters

Date Recall
Initiated:

December 2, 2005

Product:

Stainless Steel Greenfield ® Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before March 10, 2004 . The product code for these devices is M001505010.

Use:

A vena cava filter is a small cone-shaped device 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.

Recalling Firm:

Boston Scientific Corporation
1 Scimed Place
Maple Grove , Minnesota 55311-1565

Reason for Recall:

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, putting patients at risk of cardiac and pulmonary embolization. Potential adverse events include serious patient injury or death.

Public Contact:

Jonas Runquist, RAC
Director, Regulatory Affairs, Cardiovascular
Boston Scientific Corporation
2 Scimed Place
Maple Grove , Minnesota , 55311
763-494-2837

FDA District:

Minneapolis

FDA Comments:

• Customers should return all unused devices with a “use before date” prior to March 2007 to Boston Scientific.
• This recall does not affect vena cava filters that have been implanted in patients.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Physicians and patients who have questions about the recall may contact Boston Scientific at 1-888-272-1001.