In addition to warning IVC filter maker C. R. Bard about medical device reporting and quality system violations, the U.S. Food and Drug Administration (FDA) has also cracked down on two Bard IVC filter recovery devices that have not been cleared for market. In its July 13 letter, the FDA held Bard accountable for adulteration/misbranding violations at its Tempe, Arizona, facility. The charges concern Bard’s Recovery Cone Removal System Models RC-15 and FBRC.
The Bard Recovery Cone Removal System is used to retrieve Bard inferior vena cava (IVC) filters from patients in whom they have been implanted. IVC filters are tiny, spider-shaped devices inserted into the vena cava to intercept blood clots on their way to vital organs, thereby preventing stroke and other life-threatening events. Despite the life-saving benefits they have been advertised to confer, Bard IVC filters have been accused of doing more harm than good. Plaintiffs in Bard IVC filter lawsuits claim that Bard released a defective and inadequately researched product, which is prone to piercing the vena cava or migrating to major organs, resulting in severe injury and sometimes death.
In 2010, the FDA issued a safety alert about the long-term risks of retrievable IVC filters. The agency urged surgeons to remove IVC filters at the soonest possible opportunity to reduce risk of vena caval perforation and device migration. The Bard Recovery Cone Removal System is designed to accomplish this task—and it is this specificity of design that has led the FDA to suspend distribution of the device’s RC-15 and FBRC models.
By law, certain manual devices intended for general surgical use do not require premarket certification. But according to the FDA, there is evidence that both the RC-15 and FBRC models of the Recovery Cone Removal System are intended for specialized medical use—namely, the retrieval of Bard G2 IVC filters. These devices do not fall into the category of general-use surgical instruments, and therefore require clearance from the FDA before they can legally be marketed. The FDA has deemed these two device models misbranded and requested that Bard cease distribution of its RC-15 and FBRC Recovery Cone Removal Systems until premarket approval is requested and granted.
If you or someone you know was injured by a faulty IVC filter, you may qualify for legal compensation through an IVC filter lawsuit. Contact Lopez McHugh today for a free consultation with one of our IVC filter attorneys.