FDAnews Device Daily Bulletin

Concert Medical Issues Recall Due to Galeo Pro Guidewire Coating Malfunctions

Nov. 14, 2016

Concert Medical has issued a recall notice for certain lots of its Galeo Pro coronary guidewires over issues with the polytetrafluoroethylene (PTFE) coating separating from the device.

The PTFE coating separating or detaching on the device could cause PTFE particulate to enter the blood stream which could lead to thrombotic events such as blood clots thus lead to potential serious injury or death.

Concert Medical said it has received one report of PTFE coating separation during procedure, but no injuries or deaths were reported related to the separation, according to the notice.

The affected products being recalled were manufactured between June 2013 and May 2015. — Cynthia Jessup

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