FDA: Class I recall of SOLOPATH Balloon Expandable TransFemoral System, Re-Collapsible Balloon Access System

Editor's Note

The Food & Drug Administration on May 30 identified the recall by Terumo Medical Corporation (Somerset, New Jersey) of its SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System as Class I, the most serious.

The recall was initiated because the tip could dislodge from the outer rim of the sheath resulting in a loss of smooth transition from the surface of the tip to the outer surface of the expandable sheath. A total of 14 incidents have been reported, including two injuries.

Distribution dates are July 22, 2016, to March 13, 2019.