January 14, 2011
Vascular Filter Warning: FDA issues cautionary letter
On August 9, 2010, the FDA issued a warning letter regarding the risks associated with retrievable Inferior Vena Cava (IVC) Filters made by C.R. Bard, Inc. Although the device has not yet been officially recalled, the FDA has received more than 900 adverse event reports involving this device, stating that certain filters may fracture and cause parts of the device to migrate through the bloodstream to other areas of the body.
An IVC filter is a type of vascular filter implanted by surgeons to prevent fatal pulmonary emboli, and its function is to prevent blood clots from traveling to the lungs. This product is currently classified by the FDA as a Class II medical device, meaning the device requires an additional level of control such as special labeling requirements and post-market surveillance. Consumer News Weekly reports that the Bard IVC filters have higher rates of injury compared to other similar devices.
Bard is the parent company of Davol, Inc., the manufacturer responsible for the recalled Composix® Kugel® Mesh hernia patch, and has also recently voluntarily recalled its XenMatrix hernia and abdominal surgical graft. The company currently faces thousands of lawsuits involving the Composix Kugel Mesh hernia repair patch in both federal and state court.