Call Today for a FREE Confidential Case Review - Toll-Free 24/7 (866) 920-0753

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 currently accepting IVC filter induced injury cases in all 50 states. If you or somebody you know has been injured by the Bard Recovery, G2, or G2 Express, you should contact our lawyers immediately for a free case consultation. 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.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

Free Case Evaluation

The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiff’s law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firms reputation for providing personal attention to each and every client we represent.

No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.