Ethicon Issues Safety Alert for Endopath Echelon Vascular Reload
Surgical Stapler Cartridge Correction
Endopath Echelon Vascular White Reload for Advanced Placement Tip
Source: FDA
Urgent Class I Medical Device Recall
Ethicon Endo-Surgery, LLC has issued an urgent correction for its Endopath Echelon Vascular White Reload for Advanced Placement Tip (35 mm, 4-row). This device is used exclusively with the Echelon Flex Powered Vascular Stapler (Model PVE35A) during surgery to simultaneously cut and staple tissue.
The FDA has classified this correction as a Class I recall, its most serious category, due to the risk of inadvertent device lockout during surgery. While the stapler momentarily activates, it fails to cut or staple tissue—potentially delaying the procedure and increasing the risk of life-threatening complications such as hemorrhage.
What’s the Issue?
A mechanical error in some reloads may cause the stapler to lock up without firing, requiring extra steps to remove it from the patient. Although the design minimizes the risk of cutting or damaging tissue during lockout, the failure can disrupt surgery and, in rare cases, lead to serious injury or death. To date, one death and one injury have been reported.
Affected Product
- Product: Endopath Echelon Vascular White Reload (35 mm, 4-row)
- Model: VASECR35
- UDI: 10705036014591
- Used with: Echelon Flex Powered Vascular Stapler (PVE35A)
- Action Required: Review and follow updated instructions for use. View the video training (via QR code or provided link) and ensure staff understand how to handle lockout events.
What You Should Do
- Confirm that all personnel using the stapler and reload are familiar with the updated Instructions for Use.
- Watch the training video on lockout management.
- Share this notice with all relevant clinical staff.
- Post the communication where affected devices are used.
- Complete and return the Business Reply Form within 3 business days.
- If product was distributed to other sites, notify them immediately.
Ethicon representatives will follow up to ensure users are trained and informed.
Contact
For questions or support, call the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266), option 4 — available 24/7.
Read the FDA recall notice here.
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