FDA-Device2021-01-13Class II
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Boston Scientific Corporation
Hazard
The rotating luer fitting at the distal end of the delivery system handle may become detached from the nose of the delivery during device preparation, stent delivery or use, resulting in delay or procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity
Sold states
US Nationwide distribution - Foreign: TBD.
Affected count
78 units
Manufactured in
300 Boston Scientific Way, Marlborough, MA, United States
Products
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0778-2021Don't want to check this manually?
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