FDA-Device2024-02-07Class II
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Ethicon Endo-Surgery Inc
Hazard
There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue apposition that could require surgical intervention. This may result in bleeding, prolonged surgery, or surgical delay.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada and Brazil.
Affected count
22,616 (US), 4,476 (OUS)
Manufactured in
4545 Creek Rd, Blue Ash, OH, United States
Products
ENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath Stapler, Endoscopic Linear Cutter Reload (+Gripping Surface technology), 45MM WHITE VASCULAR/THIN, Product No. GST45W
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0834-2024Don't want to check this manually?
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