# FDA recall Z-0668-2020

> **Boston Scientific Corporation** · Class II · device recall initiated 2019-11-18.

## Product

Habib EUS RFA, 20mm electrode active tip, Material Number/UPN: 6700 - Product Usage: The Habib EUS RFA is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radiofrequency generator.

## Reason for recall

During testing on the Habib EUS RFA device, a temperature increase was observed at the tip of the EUS-FNA needle. It was determined that capacitive 5 coupling presents a risk of energy transfer from the Habib EUS RFA active tip to the  introducer device. This capacitive coupling could result in thermal injury to tissue outside of the targeted treatment area due to its use with an un-insulated EUS-FNA needle requiring little or no medical intervention.

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, CT, FL, NJ, NY, MA, MD, MN, TN, TX and countries of Canada, India, Australia, Great Britain, Greece, Spain.

## Key facts

- **Recall number:** Z-0668-2020
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-18
- **Report date:** 2019-12-18
- **Termination date:** 2020-06-25

- **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-0668-2020

## Citation

> AI Analytics. FDA recall Z-0668-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0668-2020. Source: US FDA. Licensed CC0.

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