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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1517-2024 |
| Event ID | 94165 |
| Event 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the country of Japan. |
| Quantity | 13 units (Japan) |
| Recall Reason | 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 |
| Device Classification | 20240417 |
| Device Code Info | GTIN: 08714729880691 Lot Numbers: 32234291 |
| Center Classification Date | 20240411 |
| Recall Initiation Date | 20240220 |
| Recalling Firm | Boston Scientific Corporation |
| Initial Notification | Letter |
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