# FDA recall Z-2327-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2021-07-23.

## Product

TheraSphere Administration Set, REF OTT-SPE-FP-226 (990226.SPE)

## Reason for recall

Potential for leaks and loosening at the patient catheter connection

## Distribution

Worldwide distribution - US Nationwide and the countries of Belgium, Canada, Germany, Spain, France, United Kingdom/Great Britain, Hong Kong, Ireland, Israel, India, Italy, Netherlands, Poland, Portugal, Saudi Arabia, Singapore, Switzerland, Turkey, and Argentina.

## Key facts

- **Recall number:** Z-2327-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-23
- **Report date:** 2021-08-25

- **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-2327-2021

## Citation

> AI Analytics. FDA recall Z-2327-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-2327-2021. Source: US FDA. Licensed CC0.

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