Medical Device Recall: Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
Ethicon Endo-Surgery Inc · April 22, 2025
Reason for Recall
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.
Distribution
US distribution nationwide. OUS distribution to EMEA, LATAM, APAC, and Canada.
States Affected
NATIONWIDE
Quantity Affected
678,526
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1746-2025
Status: ongoing
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