# FDA recall Z-0675-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-11-18.

## Product

IceSeed" 1.5 90¿ Cryoablation Needle

## Reason for recall

Complaint trend regarding needle shaft gas leaks.

## Distribution

Nationwide

## Key facts

- **Recall number:** Z-0675-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2020-11-18
- **Report date:** 2020-12-30

- **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-0675-2021

## Citation

> AI Analytics. FDA recall Z-0675-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0675-2021. Source: US FDA. Licensed CC0.

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