C.R. Bard IVC Filter
C.R. Bard IVC Filters Linked to Reports of Hemorrhaging, Organ Damage, and Death
C.R. Bard’s inferior vena cava filters (IVC Filters) were approved by the FDA in 2003 to help prevent pulmonary embolism by keeping blood clots from travelling to the lungs.
By 2005, they had been removed from the market due to various safety concerns. Since their removal, the FDA has received nearly 1,000 adverse event reports involving IVC filters, including reports of hemorrhaging, organ damage, and death.
BARD RECOVERY IVC FILTER AND G2 IVC FILTER
In 2003, C.R. Bard introduced the Recovery IVC filter to the market. After numerous reports of device breakage, C.R. Bard redesigned the device to make it more resistant to fractures. The new and improved Bard G2 IVC filter was released in 2005. Unfortunately, this device has also been linked to numerous reports of filter fracture and migration.
FDA ADVERSE EVENTS REPORTED TO THE FDA
According to a 2010 FDA Safety Communication, by the time the device was removed from the market in 2005, the agency had received 921 adverse reports involving C.R. Bard IVC filters, including:
- 328 reports of device migration
- 146 reports involving embolizations or detachment of the device components
- 70 reports of IVC perforation
- 56 reports of IVC filter fracture
BARD IVC FILTER INJURIES
- Severe and Persistent Chest Pain
- Filter Fracture, Migration or Erosion
- Injury to the Heart, Lung or Vena Cava
- Cardiac or Pericardial Tamponade