Complications

Reported Problems/Injuries Related to C.R. Bard Retrievable Filters

Over the last several years, reports of injuries linked to the failure of one particular retrievable IVC Filter have been filed with the United States Food and Drug Administration (FDA). Those filters, based on the original design of the Recovery IVC filter, are manufactured and sold by C.R. Bard, a large manufacturer of IVC filters. The C.R. Bard filters that have been implicated in the injury reports are:

• Recovery
• G2
• G2 Express
• Eclipse
• Meridian and
• Denali.

Each of these retrievable IVC filters has been implicated in reports of injuries stemming from migration, fracture, perforation, tilting, loosening or other failure of the filter. According to published reports, C.R. Bard has sold approximately 34,000 of these retrievable IVC filters. Although C.R. Bard halted sales of these IVC filters in 2005, the filters were not recalled so unsuspecting physicians continued to implant the filters in unsuspecting patients. Currently, there are over 20,000 patients who have these IVC filters in their bodies.

In August 2010, the United States Food and Drug Administration (FDA) issued a Safety Communication in which it notified physicians of its concern that retrievable IVC filters, though intended for temporary implantation, were not being removed in a timely fashion thereby subjecting patients to unnecessary risks associated with prolonged implantation of the filters. These risks include:

• Filter Migration,
• Filter Fracture,
• Filter Embolization and
• Perforation of the Inferior Vena Cava.

This Safety Alert was updated on May 6, 2014 providing additional clinical information and data about patient risks associated with delayed removal of retrievable IVC filters.

The FDA has received over 900 Adverse Event Reports in which one of these Recovery family - IVC filters has been linked to patient injuries. These include 27 reported deaths associated with the failure of a Recovery-family IVC filter.

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