Terumo’s Solopath Transfemoral System and Recollapsible Balloon Access System Recalled for Dislodging Issues
The class I recall was initiated following 14 incidents, including two cases in which patients were injured.
Today, the US Food and Drug Administration announced a recall of the Solopath balloon expandable transfemoral system and the Solopath recollapsible balloon access system, both made by Terumo Medical Corporation. This class I recall, the most serious type, follows a voluntary recall initiated by the manufacturer in April 2019 and a product discontinuance notification.
The Solopath systems are designed for low-profile, large-bore vessel access during procedures such as TAVR.
According to the FDA, Terumo has received 14 reports of incidents in which the tip of the device dislodged from the outer diameter of the sheath, resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable sheath. No deaths have been reported. However, two patients were seriously injured as a result of the malfunctioning devices.
“Use of the affected devices could cause vessel tears (dissection), false lumen, blood between the two outer layers of an artery (pseudoaneurysm), hemorrhage, inability to transition through the skin to the iliac artery in the hip area, vessel perforation, and vessel disruption, which may result in additional medical intervention, increased procedure time, or death,” the recall notice states.
The FDA says 3,474 devices manufactured from June 2016 through January 2019 are affected by the recall, including all model and lot numbers.
US Food and Drug Administration. Terumo Medical Corporation recalls SOLOPATH balloon expandable transfemoral system and re-collapsible balloon access system due to dislodgement of the fairing tip from the sheath. Published on: May 30, 2019. Accessed on: May 30, 2019.