Aesculap Miethke Shunt System Recalled for Missing Patient Labels
Aesculap Inc. is recalling four units of the Miethke Shunt System miniNAV Valve due to missing patient labels. No patient injuries have been reported.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, and the source explicitly states there are no patient injuries. The issue is a documentation/labeling defect, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Aesculap Inc. has initiated a recall of four units of the Miethke Shunt System, specifically the miniNAV Valve (Catalog No: FV660T, Lot No: 4506022655). The recall was initiated because the devices were found to be missing patient labels.
The Miethke Shunt System is a medical device intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. The affected units were distributed in Oklahoma and Wisconsin.
The source text states that there are no patient injuries resulting from this issue. Patients and healthcare providers with these specific devices should contact Aesculap Inc. for further instructions.
The recalled product
- Product
- Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
- Manufacturer
- Aesculap, Inc.
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog No: FV660T Lot No: 4506022655
Distribution
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