FDA Issues Warning Letter to C.R. Bard Regarding IVC Filter Retrieval Device Violations
The FDA sent a warning letter to Bard regarding the device it manufactures and markets, and in particular, the Recovery Cone Removal System that is used to retrieve the company’s “optional” G2 IVC filters from the human body.
C.R. Bard, Inc. has been making these filters, and others with a similar purpose, to prevent deep vein thrombosis (DVT), pulmonary embolism (PE), and venous thromboembolism (VTE). The device is a rounded, cage-like device with up to 12 wires (“struts”) that are implanted in the vena cava and capture blood clots rising from the feet, knees, legs, and hips. Some of the struts have hooks that are used adhere the implanted device to the vena cava wall.
The agency stated the removal device was being marketed in the U.S. “without marketing clearance or approval, in violation of the [Federal Food, Drug, and Cosmetic] Act.”
Further, the warning letter further stated Bard had misbranded the retrieval system because the company “did not notify the agency of [its] intent to introduce the device into commercial distribution.”
The warning also highlighted the fact that the device was adulterated due to lack of premarket approval or an exception as an investigational device, and that an implantee experienced “embolization of a detached filter arm with associated areas of hemorrhage and necrosis in the right lung [that] was filed as a malfunction Medical Device Report [MDR] and should have been filed as a death.”
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