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 the blood stream.
PTFE particulate in the blood stream could lead to thrombotic events such as blood clots, which could potentially lead to serious injury or death.
Concert Medical said it has received 1 report of PTFE coating separation during procedure, but no injuries or deaths were reported related to the separation, according to an urgent field safety notice.
The affected products being recalled were manufactured between June 2013 and May 2015, the company said. The company advised customers to discontinue use of the affected lots of the Galeo Pro, and return the products to the company.
Concert Medical hasn’t been the only company haunted by coating separation issues. Last month, Medtronic(NYSE:MDT) issued another recall related to a coating issue that’s affected its Pipeline device used for brain aneurysm treatment.
Originally developed by Ev3, the Pipeline device is designed to divert blood from the aneurysm. Covidien acquired Ev3 in the summer of 2010, paying $2.6 billion in cash, and the technology moved to Medtronic with its $50 billion buyout of Covidien last year. The FDA approved Pipeline in March 2011.
In April 2014 Covidien recalled some lots of the device, as well as its companion Alligator embolism retrieval device, after receiving reports that the plastic coating applied to the guidewire can delaminate and detach from the devices. The coating, made of polytetrafluoroethylene, is designed to reduce friction between the devices and the guidewire. No reports of injury or death were reported, the company said at the time. The FDA cleared Pipeline’s return to market in August 2014, after Covidien worked with its suppliers to correct the problem.