Aesculap Valve XS Atrium Retractor Blades Recalled Due to Corrosion
Aesculap is recalling 41 Valve XS Atrium Retractor blades distributed in New York because corrosion was found on a ball joint caused by incorrect manufacturing materials.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The hazard involves corrosion of a surgical instrument, which poses a risk of harm during surgery, but no injuries or illnesses are reported in the source text.
Plain-English summary
Aesculap, Inc. is recalling 41 units of the Valve XS Atrium Retractor, specifically various blade models including the FC424R, FC425R, FC426R, FC428R, FC429R, FC430R, FC431R, FC432R, FC433R, FC434R, FC435R, FC436R, and the FC420R Complete Set. These medical devices are used in heart surgery for the temporary dilation of the left atrium in mitral valve surgery and for assistance in tricuspid valve surgery. The affected units were distributed to the state of New York.
The recall was initiated after a customer complaint reported that a hospital's central sterile service department found corrosion on the ball joint of an FC424R blade. An investigation determined that the corrosion was caused by the use of incorrect material in the manufacturing of the disk spring of the ball joint by the supplier.
This is an FDA Class II recall. No specific instructions for consumers are provided in the source text, but the devices are intended for professional medical use in surgical settings.
The recalled product
- 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.
- Manufacturer
- Aesculap, Inc.
- Affected units
- 41
Distribution
Distributed in 1 state:
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