COBRA FUSION 150 Ablation System recall
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Why was COBRA FUSION 150 Ablation System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI - none Lot Numbers - All lots within expiry
- Product
- COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
- Recalling firm
- AtriCure, Inc.
- Quantity
- 6176 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
- Recall date
- February 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)