Such a rebuff is also rare: Most device companies voluntarily recall products when a serious problem is discovered, and almost all do it when FDA suggests it. If the formal request is not heeded, FDA can seek a court order mandating the recall. Given thatÂ what'sÂ in playÂ are high-risk tissue-based devices such as heart valves, it would not be surprising at all if FDA took this to court. Yet, for now, Shelhigh remains defiant. Its marketing director says FDA has not presented any data to justify its recall request. So this is not the end of the story. Don't be surprised if Shelhigh hires Larry Pilot, if it hasn't already.