Posts Tagged 'bard recovery cone removal system'

Bard Waited on 2004 Report Urging IVC Filter Investigation

bard waited ten months to pull recovery filterIn a recent story on Bard inferior vena cava (IVC) filters, NBC News released a previously confidential report comparing the relative safety of Bard’s Recovery IVC filter with that of competing products. The report found that the Recovery filter posed a greater risk of filter fracture, device migration, and death than other retrievable and permanent IVC filters.

But what’s most surprising about this report is the date—December 2004. ...

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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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