Recall Z-1514-2024 ยท PIF Gastrointestinal Tubes With Enteral Specific Connectors
Boston Scientific Corporation
EndoVive 20Fr Push Standard PEG Kit w/ENFit (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: M00509051
| Date | Apr 11, 2024 (initiated Feb 20, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Process design |
| Action | Boston Scientific issued Urgent Medical Device Removal letter on 2/20/24 via courier. Letter states reason for recall, health risk and action to take: is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected devices may have been transferred. This removal affects only the products listed in Attachment 1 (Affected Products). No other material numbers or batches are impacted by this removal. Further distribution or use of any remaining product affected by this removal s |
| Quantity | 572 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150679 | EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit C Boston Scientific Corp, May 29, 2015 |