IVC Filter Failure

IVC Maker Committed Quality System Violations

bard found to have committed quality violationsA recent letter from the U.S. Food and Drug Administration (FDA) reveals that IVC maker C. R. Bard committed several quality system violations at its facilities in Queensbury, New York, and Tempe, Arizona. According to the FDA, Bard failed to “establish and maintain procedures for receiving, reviewing, and evaluating complaints as required by [law].” The agency cites several instances in which Bard’s quality system did not ensure adequate evaluation of ...

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Bard Failed to Submit IVC Filter Reports

bard failed to submit IVC filter reportsIn a July 13 letter, the U.S. Food and Drug Administration (FDA) called out IVC filter maker C. R. Bard on medical device reporting violations. Inspection of the Bard Peripheral Vascular facility in Tempe, Arizona, in late 2014 revealed that Bard failed or refused to submit reports regarding the safety of its IVC Denali Filter Delivery System.

Bard is already in hot water for its allegedly defective inferior vena ...

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FDA Cracks Down on Unapproved Bard IVC Filter Recovery Devices

fda targets bard in quality system violation investigationIn 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 ...

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FDA Finds Bard Violated Federal Law In Manufacture and Marketing of IVC Filters and Threatens Seizure, Injunction, and Civil Money Penalties

FDA finds Bard violated federal lawOn July 13, 2015, The FDA warned Bard that it has been illegally marketing the devices used to retrieve its IVC filters, which are known as the Recovery Cone Removal System, since 2003. Bard’s marketing of these devices is illegal as Bard has never sought clearance from the FDA to use these devices in humans. Thus, Bard has essentially been subjecting patients to an illegal research trial without the safeguards and oversight ...

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Are Retrievable IVC Filters Worth the Risk?

retrievable ivc filters give no benefitThe health risks posed by retrievable inferior vena cava (IVC) filters have long been the subject of much scrutiny. IVC filter lawsuits allege that companies like C. R. Bard and Cook Group released defectively designed IVC filters onto the market without adequately testing for dangerous side effects. In legal battles, IVC filter manufacturers have frequently stated that the devices’ health risks are outweighed by their potentially life-saving benefits. However, recent ...

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Bard IVC Filter Lawsuit Survives Motion to Dismiss

bard failed at a recent attempt of having an ivc filter lawsuit dismissedA Florida federal judge recently denied a motion to dismiss filed by C. R. Bard, Inc., in an IVC filter lawsuit. The judge dismissed a failure-to-warn claim, but allowed the Bard IVC lawsuit to proceed on the grounds of defective design. According to the court order, the judge found that the plaintiff may be able to convince a jury that the Bard ...

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