# FDA recall Z-2680-2020

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-06-04.

## Product

Ablation Galil Technology, Three IceFORCE  2.1 CX Prostate Cyroablation Kit Visual ICE System, Prescription Only    Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

## Reason for recall

The needle surface deteriorated due to unexpected electrolysis during procedure.

## Distribution

Nationwide Distribution to states of: AL, AR, AZ, CA,  CO, CT,  DE, DC, FL, GA, HI, IA, ID, KS, LA, MA, MD, ME, MN, MO, MS, NC, ND, NE, NJ, NM, NY,  NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI  WV, and WY and the country of: Canada.

## Key facts

- **Recall number:** Z-2680-2020
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-06-04
- **Report date:** 2020-07-29
- **Termination date:** 2024-09-23

- **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-2680-2020

## Citation

> AI Analytics. FDA recall Z-2680-2020. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-2680-2020. Source: US FDA. Licensed CC0.

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