# FDA recall Z-0327-2022

> **Boston Scientific Corporation** · Class II · device recall initiated 2021-10-21.

## Product

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.  UPN:  M00545960

## Reason for recall

Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0327-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-10-21
- **Report date:** 2021-12-08

- **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-0327-2022

## Citation

> AI Analytics. FDA recall Z-0327-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0327-2022. Source: US FDA. Licensed CC0.

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