Recall Monitor
Health ProductsType I recall

Endopath Echelon Vascular Reloads

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Endopath Echelon Vascular Reloads
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type I
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Products

Affected productsLot or serial numberModel or catalogue number
Endopath Echelon Vascular ReloadsAll lots distributed since 2024-05-30 and with expiry dates starting 2026-08-31VASECR35

Issue

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

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