AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip… — Class II medical device recall Z-0377-2017
Terminated recall by AtriCure, Inc., reported 2016-11-16, distributed nationwide. There is a potential for a component failure of the device which could necessitate medical intervention.
| Recall number | Z-0377-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AtriCure, Inc., Mason, OH, United States |
| Recall initiated | 2016-09-22 |
| Classified | 2016-11-09 |
| Reported by FDA | 2016-11-16 |
| Terminated | 2018-02-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, PL |
| Quantity | 298 |
| Lot numbers | 65622, 66773 |
| Model numbers | PRO235, PRO240, PRO245, PRO250 |
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 for recall
There is a potential for a component failure of the device which could necessitate medical intervention.
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-0377-2017. 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.