COBRA FUSION 50 — Class II medical device recall Z-0829-2019
Terminated recall by AtriCure, Inc., reported 2019-02-20, distributed in AL, AR, AZ, CA, CO, CT, FL, ID…. There is a potential for patients undergoing ablation to experience an elevated risk for TE; during stand-alon
| Recall number | Z-0829-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AtriCure, Inc., Mason, OH, United States |
| Recall initiated | 2019-01-22 |
| Classified | 2019-02-14 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2020-05-12 |
| Distributed | 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 |
| Countries outside the US | AE, AT, BE, CH, CZ, DE, FR, GB, IT, KW, LV, NL, PL, SE |
| Quantity | 1,288 units |
| UPC / GTIN / UDI-DI | 00818354012811 |
| Model numbers | 700-002 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0829-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.