Aesculap Miethke Shunt System Accessories Recalled for Incorrect MR Safety Labeling
Aesculap, Inc. is recalling Miethke Shunt System accessories because the shelf box labels incorrectly display an MR conditional symbol. The product is actually MR unsafe, and the correct information is only provided in the Instructions for Use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall involving a labeling error that could lead to incorrect MRI safety assumptions, but no injuries or illnesses are reported in the source text.
Plain-English summary
Aesculap, Inc. is recalling 772 units of Miethke Shunt System accessories due to a labeling error on the shelf box. The label incorrectly displays the MR conditional symbol, whereas the product is MR unsafe and should have no symbol. The correct safety information is only required to be included in the Instructions for Use (IFU).
The Miethke Shunt System is intended to shunt cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. The affected accessories are identified by material numbers FV400T through FV409T, FV499T, and FV790T through FV796T.
The recall involves worldwide distribution and US nationwide distribution. Users should refer to the Instructions for Use for accurate MR safety information.
The recalled product
- Product
- Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
- Manufacturer
- Aesculap, Inc.
- Hazard
- Affected units
- 772
Distribution
Distributed nationwide across the United States.
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