# FDA recall Z-1517-2024

> **Boston Scientific Corporation** · Class II · device recall initiated 2024-02-20.

## 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

## Distribution

Worldwide distribution - US Nationwide and the country of Japan.

## Key facts

- **Recall number:** Z-1517-2024
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-20
- **Report date:** 2024-04-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1517-2024

## Citation

> AI Analytics. FDA recall Z-1517-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1517-2024. Source: US FDA. Licensed CC0.

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