FDA Device recall Z-0566-2016
Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery
- FDA Device
- Class II
- terminated
- Published 2016-01-06
On 2016-01-06 the FDA classified a Class II recall of Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in heart surgery by Aesculap, citing 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 tha….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0566-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-17 |
| Published | 2016-01-06 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Aesculap |
| Distribution | NY |
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
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
Identifiers
| code_info | Product Information All lots affected Product Description FC424R Valve XS Atrium Lift Ret. Blade50X35 FC425R Valve…Product Information All lots affected Product Description FC424R Valve XS Atrium Lift Ret. Blade50X35 FC425R Valve XS Atrium Lift Ret. Blade60X35 FC426R Valve XS Atrium Lift Ret. Blade70X35 FC428R Valve XS Atrium Lift Ret. Blade50X45 FC429R Valve XS Atrium Lift Ret. Blade60X45 FC430R Valve XS Atrium Lift Ret. Blade70X45 FC431R Valve XS Atrium Lift Ret. Blade25X20 FC432R Valve XS Atrium Lift Ret. Blade25X25 FC433R Valve XS Atrium Lift Ret. Blade40X25 FC434R Valve XS Atrium Lift Ret. Blade50X25 FC435R Valve XS Atrium Lift Ret. Blade25X40 FC436R Valve XS Atrium Lift Ret. Blade25X50 FC420R Valve XS Atrium Lift Ret. Blade Complete Set |
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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-0566-2016%22
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