Bard Marquee 12g X 10 cm

Issue

In September 2024, BD initiated a field action for specific lots of the Marquee™ Disposable Core Biopsy Instruments that were potentially manufactured missing the backend notch retention feature on the needle (figure 1), which results in inadequate securing of the needle inside the device. As part of the corrective actions associated with that issue, BD inspected all remaining needle sub-assembly lots that remained in stock at the manufacturing location. BD has since identified that one sub-assembly lot that underwent this inspection may not have been adequately sorted, thus there is a potential for specific lots of the Marquee™ Disposable Core Biopsy Instruments that were manufactured with that sub-assembly to contain needles that were not adequately inspected for the presence of the backend notch.