Aesculap Miethke Ventricular Catheter Recalled Due to Deflector Movement Issues
Aesculap, Inc. is recalling 48 units of the Miethke Ventricular Catheter with Deflector because the deflector did not move freely in three reported cases.
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 3/5 (High).
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, and the hazard involves a mechanical failure of a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Aesculap, Inc. is recalling 48 units of the Miethke Ventricular Catheter with Deflector/Miethke Shunt System. The device is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum. The recall was initiated after the company received information regarding three complaints in which the deflector did not move freely on the ventricular catheter.
The affected products are identified by Catalog Numbers FV431T, FV434T, FV433T, FV459T, FV078P, FV494T, FV676T, and FV324T. Specific Lot Numbers are also listed in the official recall documentation. The products were distributed in the United States, including the states of Pennsylvania, Kentucky, New York, Rhode Island, South Carolina, Kansas, Texas, Connecticut, Tennessee, and Washington.
Healthcare providers and patients should contact Aesculap, Inc. for instructions on how to handle the recalled devices. The source text does not specify a particular action for consumers, but standard protocol for medical device recalls involves contacting the manufacturer or the FDA for guidance on replacement or return.
The recalled product
- Product
- Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
- Manufacturer
- Aesculap, Inc.
- Affected units
- 48
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 (20)
- Catalog No: FV431T
- FV434T
- FV433T
- FV459T
- FV078P
- FV494T
- FV676T
- FV324T Lot No: 4505150452
- 4505156642
- 4505164365
- 4505134636
- 4505150384
- 4505156634
- 4505246780
- 4505394315
- 4505150371
- 4505174213
- 4505187583
- 4505366616
- 4505134635
Distribution
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