COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
Reported: February 20, 2019 Initiated: January 22, 2019 #Z-0829-2019
Product Description
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
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.
Details
- Recalling Firm
- AtriCure, Inc.
- Units Affected
- 1288 units
- 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
- Location
- Mason, OH
Frequently Asked Questions
What product was recalled? ▼
COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002. Recalled by AtriCure, Inc.. Units affected: 1288 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2019. Severity: Moderate. Recall number: Z-0829-2019.
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