FDA-Device2024-02-28Class II
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Boston Scientific Corporation
Hazard
Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
Sold states
International distribution to the country of Japan only.
Affected count
0 US; 74 OUS
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1153-2024Don't want to check this manually?
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