# FDA recall Z-2533-2025

> **Boston Scientific Corporation** · Class II · device recall initiated 2025-08-05.

## Product

Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN):    1.	H74904526011;   2.	H74904526052;   3.	M0067101140;   4.	M001151050;   5.	M001151062;   6.	M00566670.   (Interventional Cardiology, Peripheral Interventions)

## Reason for recall

The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2533-2025
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-05
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2533-2025

## Citation

> AI Analytics. FDA recall Z-2533-2025. Retrieved 2026-07-25 from https://api.ai-analytics.org/recall/Z-2533-2025. Source: US FDA. Licensed CC0.

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