Medical Device Recall: EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional me
Boston Scientific Corporation · February 20, 2024
Reason for Recall
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include additional intervention to close the puncture site, bleeding, leakage of gastric contents, and aspiration
Product Description
EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated for enteral nutrition directly into the stomach in both pediatric and adult patients who are unable to consume nutrition by conventional means. UPN: M00509191
Distribution
Worldwide distribution - US Nationwide and the country of Japan.
States Affected
NATIONWIDE
Quantity Affected
13 units (Japan)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1517-2024
Status: ongoing
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