FDA Device recall Z-0653-2017
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System
- FDA Device
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System by Atricure, citing due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0653-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-22 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Atricure |
| Distribution | AL, AR, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI |
Product
COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion Magnetic Retriever System. Model Numbers: 700-001, 700-001S, 700-001MI, 700-002, and 700-003. Intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).
Reason
Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body function or structure.
Identifiers
| code_info | Specifically all lots manufactured prior to February 2016. This information can be identified as the symbol for "date…Specifically all lots manufactured prior to February 2016. This information can be identified as the symbol for "date of manufacture" on the product label as: MM-YYYY, e.g. 02-2016 or earlier. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0653-2017%22
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