The U.S. Food and Drug Administration (FDA) has issued the company, Bard, a serious warning that could impact you. Bard has failed to file customer complaints, and even a death, appropriately, and did not let the FDA know its Recovery Cone Removal System had dangerous defects. In fact, the company did not even get proper and required FDA approval to utilize this device in its use to retrieve vena cava filters that are inferior (Denali IVC Filter). The malfunctioning devices could be responsible for serious injury or death. The use of the Denali IVC filters is to catch blood clots of the legs, prior to their entry to the heart or lungs. In addition to the above, Bard is also possibly in trouble for cleaning processes for the Denali IVC filter that were not validated. The more serious warning and steps towards suspending marketing by the FDA occurred after Bard did not properly response to the FDA first bringing awareness to these issues.
If you or a loved one may have been injured as a result of the Bard Denali IVC Filter and/or Recovery Cone Removal System, be sure to contact your doctor. Also feel free to contact Inserra & Kelley Law Offices to discuss whether you are potentially entitled to compensation for potential injuries.