# FDA recall Z-0381-2022

> **Boston Scientific Corporation** · Class II · device recall initiated 2021-11-08.

## Product

Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).

## Reason for recall

Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.

## Key facts

- **Recall number:** Z-0381-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-08
- **Report date:** 2021-12-22
- **Termination date:** 2023-05-02

- **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-0381-2022

## Citation

> AI Analytics. FDA recall Z-0381-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0381-2022. Source: US FDA. Licensed CC0.

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