Recall Z-0653-2017— AtriCure, Inc.
Class II · Terminated
Class II FDA medical device recall by AtriCure, Inc., initiated 2016-09-22, terminated 2018-02-08. It names one FDA 510(k) clearance: K113475. 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..
- Recalling firm
- AtriCure, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-22
- Terminated
- 2018-02-08
- Firm location
- Mason, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.