This recall involve correcting certain devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without correction.
Affected Product
- Product Names: Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
- Unique Device Identifier (UDI)/Model: 10705036014591
- Affected Lots: 917C65, 895C93, 918C15, 938C92, 936C69, 929C38, 948C78, 990C81, 979C81, 400D82, 962C74, 506D29, 379D80, 413D56, 418D41, 419D47, 415D43, 427D07, 434D35, 442D78, 442D83, 444D96, 456D87, 455D03, 493D27, 468D88, 482D30, 502D90, 489D62, 134D80, 112D03, 155D33, 159D49, 181D11, 194D77, 125D04, 167D13, 223D59, 175D72, 234D11, 238D70, 261D10, 270D69, 317D74, 194D76, 349D54, 347D73, 317D73, 356D54, 326D66, 319D76, 338D99, 336D39, 356D53, 367D26, 378D04, 214D1
What to Do
Confirm that all personnel using Endopath Echelon Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row), product code VASECR35, understand the Instructions for Use (IFU) for the Echelon Flex Powered Vascular Stapler (product code PVE35A).
Scan the QR Code below or follow the link provided for a video demonstration on how to manage a device lockout. Note: Technical support can be accessed 24/7 by calling 1-877-ETHICON (1-877-384-4266) option 4.
On April 22, 2025, Ethicon sent all affected customers an Urgent Medical Device Correction letter recommending the following actions:
- Share the notification with all users of Endopath Echelon Vascular White Reload for Advanced Placement Tip (35 mm, 4 Row), product code VASECR35.
- Post a copy of this communication.
- If any subject product has been forwarded to another facility, contact that facility to share this information.
- Complete the Business Reply Form confirming receipt of this notice within three business days.
Reason for Correction
Ethicon Endo-Surgery is correcting this product due to an inadvertent lockout during surgical procedures. The device will momentarily activate but will not cut or staple tissue. Additional steps will be required to open it and remove it from tissue. The device has been designed such that an instrument lockout event should not lead to patient harm. During a lockout, the device may briefly activate but will not cut or staple tissue, requiring additional steps to release and remove it safely. The knife does not advance far enough to cut, staples remain below the tissue contact surface, and a built-in gap between the anvil and staple cartridge face helps prevent vessel injury during clamping and unclamping.
A representative from Ethicon Endo-Surgery, LLC will be contacting customers to ensure familiarity with all aspects of the Echelon Flex Powered Vascular Stapler instructions for use.
The use of affected product may cause serious adverse health consequences, including life-threatening hemorrhage, surgical delay, and death.
There has been one reported death and one injury related to this issue.
Device Use
The Echelon Flex Powered Vascular Stapler with Advanced Placement Tip and Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 Row) reloads are sterile, single patient use devices that simultaneously cut and staple tissue. There are four staggered rows of staples, two on either side of the cut line.
This reload is used exclusively with the Echelon Flex Powered Vascular Stapler, product code PVE35A. The instrument’s lockout feature is designed to prevent a used or improperly installed reload from being fired, or an instrument from being fired without a reload.
Contact Information
Customers in the U.S. with questions about this recall should contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266).
Additional FDA Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
