# FDA recall Z-0831-2019

> **AtriCure, Inc.** · Class II · device recall initiated 2019-01-22.

## Product

COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S

## Reason for recall

There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alone off-pump procedures where cardio pulmonary bypass (CPB) was not utilized.

## Distribution

AL, AR, AZ, CA, CT, CO, FL, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI    Internationally - Germany, Italy, Netherlands, France, Austria, United Kingdom, Poland, Czech Republic, United Arab Emirates, Sweden, Switzerland, Kuwait, Belgium and Latvia

## Key facts

- **Recall number:** Z-0831-2019
- **Recalling firm:** AtriCure, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-22
- **Report date:** 2019-02-20
- **Termination date:** 2020-05-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mason, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0831-2019

## Citation

> AI Analytics. FDA recall Z-0831-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0831-2019. Source: US FDA. Licensed CC0.

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