Endopath Echelon Vascular White Reload surgical stapler device lockout
Ethicon Endo-Surgery is recalling the Endopath Echelon Vascular White Reload surgical stapler due to reports of inadvertent instrument lockout during procedures. The lockout prevents cutting and stapling, potentially requiring conversion to open surgery; one patient death has been reported.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: A known fatality is documented in the source text, meeting the Critical threshold per the rubric regardless of other factors.
Plain-English summary
Ethicon Endo-Surgery Inc is recalling the Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row; Product code VASECR35) due to inadvertent instrument lockout reported during surgical procedures. When lockout occurs, the device momentarily activates but fails to cut or staple tissue, and additional steps are required to open and remove it from tissue.
If the user is unable to remove the locked device from tissue, potential harms to patients include surgical delay, bleeding or hemorrhage, life-threatening hemorrhagic shock, and conversion to open therapy. Two adverse events have been received, including one patient death.
The affected product was distributed nationwide in the US and internationally to EMEA, LATAM, APAC, and Canada. Affected batches are identified by the package batch codes listed in the FDA recall notice.
The recalled product
- Product
- Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35
- Manufacturer
- Ethicon Endo-Surgery Inc
- Affected units
- 678,526
Distribution
Distributed nationwide across the United States.
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