# FDA recall Z-1002-2022

> **Boston Scientific Corporation** · Class II · device recall initiated 2022-02-24.

## Product

SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101.  Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.

## Reason for recall

Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1002-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-24
- **Report date:** 2022-05-04

- **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-1002-2022

## Citation

> AI Analytics. FDA recall Z-1002-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1002-2022. Source: US FDA. Licensed CC0.

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