NEW YORK, July 31, 2015 /PRNewswire/ -- Seeger Weiss LLP is reporting that on July 13, 2015, the Federal Drug Administration (FDA) issued a warning letter to C.R. Bard, the manufacturer of Inferior vena cava (IVC) filters, for not taking adequate strides to correct violations the agency found at two of Bard's facilities. Bard was previously made aware of these violations after the FDA cited them during Inspectional Observations that occurred on November 18, 2014, through January 05, 2015, in Bard's Tempe, AZ, location and on October 6, 2014, through November 25, 2014, in its Queensbury, NY, location.
During the inspections, Bard's facility in Tempe, AZ, was found to be manufacturing the Recovery Cone Removal System (an IVC filter) without marketing clearance or approval by the FDA. According to the Agency, the facility also failed to inform the FDA of a device malfunction that was likely to lead to serious injury or death and misfiled several customer complaints—including a report of a patient's death. Meanwhile, Bard's Queensbury, NY, facility was cited with a violation for failure to validate IVC filter cleaning. The warning letter, which also suspended the marketing application of certain unapproved devices, is the next step for the FDA in pressuring Bard to address its cited violations.
IVC filters have previously been under scrutiny by the FDA. Meant to capture blood clots before they reach the heart or lungs, use of the medical device has been associated with certain adverse events. In a 2010 Safety Communication, the Agency noted that these events include: "device migration, filter fracture, embolization (movement of the entire filter or fracture fragments to the heart or lungs), perforation of the IVC, and difficulty removing the device." These sorts of events may be related to how long the IVC filter was implanted and, according to a 2013 study in JAMA Internal Medicine, can cause pulmonary emboli.
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If you believe you have been injured by an IVC filter, go to our IVC Filter Lawsuit page.
SOURCE Seeger Weiss LLP