Recall Z-0377-2017— AtriCure, Inc.
Class II · Terminated
Class II FDA medical device recall by AtriCure, Inc., initiated 2016-09-22, terminated 2018-02-15. It names one FDA 510(k) clearance: K160454. Product: AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.. Reason: There is a potential for a component failure of the device which could necessitate medical intervention..
- Recalling firm
- AtriCure, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-22
- Terminated
- 2018-02-15
- 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
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures.
Reason for recall
There is a potential for a component failure of the device which could necessitate medical intervention.
Data sourced from openFDA. This site is unofficial and independent of the FDA.