Ethicon Endo-Surgery Inc recalls Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm

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.

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

On April 22, 2025, the firm began to notify affected customers through letters titled, "URGENT: MEDICAL DEVICE CORRECTION." Customers were instructed to notify all users of the affected device and to post a copy of the communication, which reminds users of the Instrument Lockout Instructions that are part of the product IFU. ***UPDATED 8/20/2025*** In May 2025, all customers received an updated letter which stated that Ethicon would also provide in-person training to all impacted US consignees regarding managing a lockout condition.

• FDA enforcement recordOfficial FDA database entry for Z-1746-2025
• FDA 510(k) clearance · K141952The device's official FDA premarket clearance record
• FDA device classification · GDWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 878.4750The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Ethicon Endo-Surgery IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.