Aesculap Miethke Shunt System Recalled Due to Deflector Movement Issue
Aesculap, Inc. is recalling 11 units of the Miethke Shunt System because the deflector may not move freely on the ventricular catheter.
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 involves a medical device with a mechanical defect that could lead to catheter failure during surgical adjustment. Per the rubric, this is classified as High (Score 3) because it is a risk-of-harm product where specific injury or illness has not yet been reported in the source text.
Plain-English summary
Aesculap, Inc. is recalling 11 units of the Aesculap(R) Miethke Shunt System, specifically the FT040T Control Reservoir Set with Distal Catheter and FT075P 0 Ventric Cathet with Stylet and RT-ANG Guide. These central nervous system shunts are intended to shunt cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
The recall was initiated because the deflector on the ventricular catheter may not move freely. The deflector is pre-positioned at the 5 cm mark on the catheter, and surgeons may need to adjust its location before placement. In some cases, aggressively attempting to adjust the deflector has the potential to cause the catheter to fail or malfunction, though the specific consequence is not detailed in the provided text.
The affected units were distributed nationwide, including in Michigan, Pennsylvania, and Texas. The specific lot numbers involved are 4503489878, 4503792749, 4503682927, 4503508385, 4503789879, 4503800248, and 4503682935. Healthcare providers and patients should contact Aesculap, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into…
- Manufacturer
- Aesculap, Inc.
- Affected units
- 11
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 (6)
- Lots 4503489878
- 4503792749
- 4503682927
- 4503508385
- 4503789879
- 4503800248 and 4503682935.
Distribution
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