Concert Medical yesterday issued a voluntary recall notice for certain lots of its Galeo Pro coronary guidewires over issues with the polytetrafluoroethylene coating separating from the device. The company said it initiated the recall because of the risk of the PTFE coating separating or detaching on the device, which could cause PTFE particulate to enter […]
Concert Medical LLC
Concert Medical LLC’s new coronary guidewire, the Conductor line, hit the market in the U.S. about 10 months after winning 510(k) clearance from the Food & Drug Administration.
The Norwell, Mass.-based company said the FDA cleared the guidewire line in September 2009.