Medical Device Recall: EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.
Boston Scientific Corporation · December 19, 2023
Reason for Recall
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.
Distribution
International distribution to the country of Japan only.
Quantity Affected
0 US; 74 OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1153-2024
Status: ongoing
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