EndoVive 20 Fr Safety PEG Push w/ENFit Kit — Class II medical device recall Z-1517-2024
Ongoing recall by Boston Scientific Corporation, reported 2024-04-17, distributed nationwide. Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb
| Recall number | Z-1517-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2024-02-20 |
| Classified | 2024-04-11 |
| Reported by FDA | 2024-04-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 13 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 08714729880691 |
| Lot numbers | 32234291 |
Product
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1517-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.