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FDA Warning Letter for Bard IVC Filter Deaths and Injuries

FDA Warning Letter for Bard IVC Filter Deaths and Injuries

July 23, 2015 — The FDA has sent a warning letter to C.R. Bard after finding numerous violations related to IVC filters, including misclassifying serious injuries and deaths as “device malfunctions.”

Inspectors visited Bard facilities in New York and Arizona between October 2014 and January 2015.

The FDA was particularly concerned that Bard was misfiling injuries as “malfunctions,” including one death that occurred after a G2 filter broke and the detached filter arm caused severe bleeding (hemorrhage) and necrosis in the patient’s right lung.

The agency found about a half-dozen misclassified reports involving broken filters, perforation of the vena cava, pericardial effusion, surgical interventions, and more. Two reports described 10 patients who had unsuccessful surgeries to remove an IVC filter, but did not explain why.

Bard was also cited for selling the Bard Recovery Cone Removal System without FDA approval. The system retrieves the Recovery, Recovery G2, and G2X filters, but it was never cleared for use with those devices.

Inferior vena cava (IVC) filters are cage-like wire devices that are implanted in a patient’s body to catch blood clots before they get stuck in the lungs. In 2010, the FDA issued a Safety Communication after receiving nearly 1,000 reports of serious complications in the last five years — mostly in patients who were injured by temporary filters that were not removed in a timely manner.

Do I have an IVC Filter Lawsuit?

The Schmidt Firm, PLLC is evaluating IVC filter cases in all 50 states, regardless of whether you were injured or not. If you or someone you know received an IVC filter implant, please contact our lawyers immediately for a free case consultation. You may be entitled to compensation by filing a lawsuit.

Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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