FDA Device recall Z-0830-2019
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
- FDA Device
- Class II
- terminated
- Published 2019-02-20
On 2019-02-20 the FDA classified a Class II recall of COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001 by Atricure, citing 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 uti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0830-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-22 |
| Published | 2019-02-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Atricure |
| Distribution | AL, AR, AZ, CA, CO, CT, 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 |
Product
COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001
Reason
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.
Identifiers
| code_info | UDI - none Lot Numbers - All lots within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0830-2019%22
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