Recall of Wingman35 Crossing Catheters

Medical Device Safety

Yesterday, the FDA issued a safety alert warning of ReFlow Medical’s 4/22/17 lot-specific voluntary recall of its Wingman35 Crossing Catheters distributed between January 2015 and March 2016. According to the FDA, the Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. Tip splitting has the…

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California Court Rules in Favor of Women Injured by Essure

Medical Device Safety

On August 2, 2016, Judge Winifred Smith in the Superior Court of California, Alomeda County, issued a decision that allowed the claims of 14 women injured by Essure to proceed against the manufacturer, Bayer. Bayer argued that it was immune from liability and that the women were barred from bringing their claims under a doctrine…

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