Ethicon Endo-Surgery Inc recalls Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

Recall date

April 22, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1746-2025

FDA classification

Class I

Brand / firm

Ethicon Endo-Surgery Inc

Sold / distributed

US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.

Why it was recalled

Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35