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Bard Recovery IVC Filter May Have Fatal Flaw

Bard Recovery IVC Filter May Have Fatal Flaw

September 9, 2015 — Investigators with NBC News are questioning the safety and possibly forged approval of C.R. Bard’s Recovery IVC filter.

IVC filters are 1.5-inch, spider-like wire filters that are implanted in the inferior vena cava (IVC) to catch blood clots before they reach the lungs.

At least 27 deaths and hundreds of non-fatal adverse events have been linked to the Bard Recovery IVC filter over the last decade, according to NBC. Investigators also published a confidential study (PDF) linking the Recovery with a higher risk of movement, filter fracture, and death than all of its competitors.

Investigators talked to Kim Fuller, a veteran regulatory specialist who was hired by Bard to get clearance for the Recovery IVC filter after the FDA rejected its first approval application.

Fuller said she was never provided with crucial safety performance data on the Recovery and a small clinical trial raised red flags. Although she refused to sign the second approval application, her signature appeared on the document — significantly different from normal. Bard denies forging her signature.

After the Recovery was approved, concerns about its safety continued to grow. About 34,000 of the devices were implanted. After just three years on the market, Bard replaced the Recovery with a modified version called the G2. No recalls were issued.

In 2010, a study linked the Recovery and G2 with high rates of fracture and embolization. That same year, the FDA issued a Safety Communication to warn about nearly 1,000 adverse events involving retrievable IVC filters that were not removed as soon as they were no longer needed.

Do I have a Bard Recovery 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.

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