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FDA Warns Bard Regarding Customer Complaints About Recovery Cone Removal System

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According to a recent Security and Exchange Commission (SEC) filing, C.R. Bard disclosed that the company received a warning letter concerning its facilities in Glens Falls, NY and Tempe, AZ from the U.S. Food and Drug Administration alleging misfiled customer complaints, including one reporting a patient’s death.

The warning letter focused on Bard’s Recovery Cone Removal System, which is used to retrieve inferior vena cava (IVC) filters. The letter also alleges that Bard manufactured the Recovery Cone Removal System without the required clearance or approval, and failed to inform the FDA of serious malfunctions associated with the device.

What Are IVC Filters Used For?

IVC filters are designed to capture blood clots (embolisms) that form in the veins of the legs before they reach the heart or lungs. Without an IVC filter in place, there would be potential risk for the embolism to cause a blockage of the pulmonary artery, known as a pulmonary embolism, and cause difficulty breathing, chest pain, and death.

Until recently, IVC filters were only available as permanently implanted devices, but newer filters, called optionally retrievable filters, can either be left in place permanently or may be removed from the blood vessel later, when the risk of a blood clot breaking loose has passed.

Retrievable Inferior Vena Cava Filters

Retrievable inferior vena cava filters (rIVCF) were designed to provide temporary prevention from pulmonary embolism and then be removed when they are no longer necessary. Most rIVCFs are never removed because of:

  • Poor clinical follow-up
  • Failed retrieval procedures
  • Patients not being offered the opportunity for filter removal

Because rIVCFs seem susceptible to greater device-related complications, such as filter penetration of the IVC, filter migration, and filter fracture, the FDA was prompted to issue a safety alert in 2010 urging removal of retrievable inferior vena cava filters once they are deemed no longer necessary.

Several hundred IVC filter lawsuits are now moving forward against the manufacturers of these filters.  These IVC Filter lawsuits claim that the manufacturers did not satisfy safety concerns using testings and trials.