Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift… — Class II medical device recall Z-0566-2016
Terminated recall by Aesculap, Inc., reported 2016-01-06, distributed in NY. AAG received a customer complaint that corrosion had been found by a hospitals central sterile service depart
| Recall number | Z-0566-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2015-11-17 |
| Classified | 2015-12-31 |
| Reported by FDA | 2016-01-06 |
| Terminated | 2016-10-13 |
| Distributed | NY |
| Quantity | 41 |
| Reason classes | sterility |
Product
Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery. The retractor is used for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery.
Reason for recall
AAG received a customer complaint that corrosion had been found by a hospitals central sterile service department on the ball joint of an FC424R blade. Investigation revealed that the corrosion was due to incorrect material used in the manufacturing of the disk spring of the ball joint by the supplier
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-0566-2016. 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.