CLASS II Device recall · Reported 6 Jan 2016 · FDA Enforcement Report
Valve XS Atrium Retractor FC429R 52154756 The Valve XS recalled
Aesculap is recalling Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Lift Retractor is used in, distributed in New York. The recall was initiated on 17 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0566-2016
- FDA event ID
- 72712
- Recalling firm
- Aesculap, Center Valley, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2015
- FDA classified
- 31 Dec 2015
- Reported
- 6 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 17 Nov 2015 | Recall initiated by company | |
| 31 Dec 2015 | Classified by FDA | +44 days |
| 6 Jan 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to state of: NY.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
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
Where was it sold?
US Distribution to state of: NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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