A 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 ...
Bard Failed to Submit IVC Filter Reports
Posted July 30, 2015 in Drug and Medical Device Lawsuits | IVC Filter Failure | Product News and Recalls
In 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 ...
continue reading...FDA Cracks Down on Unapproved Bard IVC Filter Recovery Devices
Posted July 29, 2015 in Drug and Medical Device Lawsuits | IVC Filter Failure | Product News and Recalls
In 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 ...
FDA Finds Bard Violated Federal Law In Manufacture and Marketing of IVC Filters and Threatens Seizure, Injunction, and Civil Money Penalties
Posted July 23, 2015 in Drug and Medical Device Lawsuits | IVC Filter Failure | Product News and Recalls
On 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 ...
Are Retrievable IVC Filters Worth the Risk?
Posted July 6, 2015 in Drug and Medical Device Lawsuits | IVC Filter Failure | Product News and Recalls
The 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, ...
IVC Filter Maker Cook Group to Get New President
Posted June 27, 2015 in Drug and Medical Device Lawsuits | IVC Filter Failure | Product News and Recalls
According to The Indianapolis Star, IVC filter company Cook Group will have a new president come this July. Current president Kem Hawkins will step down next month after 14 years in the position. He will be replaced by the current president of Cook Medical, Pete Yonkman, who joined Cook the same year Hawkins became president.
As president of Cook Group, Yonkman will have to attend to a slew of ...
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