# FDA recall Z-1153-2024

> **Boston Scientific Corporation** · Class II · device recall initiated 2023-12-19.

## Product

EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.

## Reason for recall

Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.

## Distribution

International distribution to the country of Japan only.

## Key facts

- **Recall number:** Z-1153-2024
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-19
- **Report date:** 2024-02-28

- **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-1153-2024

## Citation

> AI Analytics. FDA recall Z-1153-2024. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1153-2024. Source: US FDA. Licensed CC0.

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