Endopath Echelon Vascular Reloads

An increase in firing issues complaints resulting from premature sled movement lockout (PMSLO) in the field. PMSLO is a safety mechanism that prevents the device from firing with a spent reload or no reload. It can accidentally be triggered if the cartridge is bumped and the sled moves out of position. Investigation has revealed that the force to bump the sled from the home position in the newest cartridge body tool is statistically lower than the previous tool, although there are no dimensional non-conformances. The IFU describes the steps to reduce risk of harm when using the device on critical vessels (i.e. proximal and distal control) and steps to safely remove the device if it locks on tissue.

Recall start date: April 29, 2025