FDA Device recall Z-0377-2017
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage,…
- FDA Device
- Class II
- terminated
- Published 2016-11-16
On 2016-11-16 the FDA classified a Class II recall of AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product is used for the occlusion of the heart's left atrial appendage,… by Atricure, citing there is a potential for a component failure of the device which could necessitate medical intervention.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0377-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-22 |
| Published | 2016-11-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Atricure |
| Distribution | US |
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.
Identifiers
| code_info | Model Numbers: PRO235, PRO240, PRO245 and PRO250 Lot Numbers: 65622 to 66773 |
|---|
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-0377-2017%22
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