Vascular surgical stapler device risks inadvertent lockout during procedures
The Endopath Echelon Vascular White Reload surgical stapler may inadvertently lock during use, preventing cutting or stapling and requiring additional removal steps. Risk of bleeding and hemorrhage if device cannot be removed from tissue.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source reports one patient death, which per the severity rubric mandates a score of 5 regardless of other factors. Additionally, this is an FDA Class I recall with life-threatening hemorrhage risk.
Plain-English summary
The Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row) surgical stapler is being recalled due to reports of inadvertent instrument lockout during surgical procedures. When lockout occurs, the device momentarily activates but fails to cut or staple tissue. If the device cannot be removed from tissue, patients face potential harms including surgical delay, bleeding, hemorrhage, life-threatening hemorrhagic shock, and conversion to open surgery.
Approximately 678,526 units have been distributed in the United States and internationally to EMEA, LATAM, APAC, and Canada. The device is manufactured by Ethicon Endo-Surgery Inc. Two adverse events have been reported, including one patient death.
The recalled product
- Product
- Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
- Manufacturer
- Ethicon Endo-Surgery Inc
- Hazard
- instrument-lockout
- hemorrhage
Distribution
Distributed nationwide across the United States.
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