# FDA recall Z-3043-2017

> **Boston Scientific Corporation** · Class II · device recall initiated 2017-06-15.

## Product

Encore(TM) 26 Inflation Device, REF Catalog Nos.:  (a) H74904526011, (b) M001151050, (c) M00566670, (d) M0067101140

## Reason for recall

Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-3043-2017
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-06-15
- **Report date:** 2017-08-23
- **Termination date:** 2020-07-22

- **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-3043-2017

## Citation

> AI Analytics. FDA recall Z-3043-2017. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-3043-2017. Source: US FDA. Licensed CC0.

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