Product Safety Recalls

Product Recall Tracker

Boston Scientific Corporation Recall 94165

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

Boston Scientific Corporation Recall 94165 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1517-2024
Event ID94165
Event DescriptionEndoVive 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
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the country of Japan.
Quantity13 units (Japan)
Recall ReasonInability 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
Device Classification20240417
Device Code InfoGTIN: 08714729880691 Lot Numbers: 32234291
Center Classification Date20240411
Recall Initiation Date20240220
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
Similar To

© 2022 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.