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.
Reported: June 11, 2014 Initiated: April 21, 2014 #Z-1676-2014
Product Description
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.
Reason for Recall
AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Details
- Recalling Firm
- Aesculap, Inc.
- Units Affected
- 48
- Distribution
- US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
- Location
- Center Valley, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Aesculap, Inc.. Units affected: 48.
Why was this product recalled? ▼
AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 11, 2014. Severity: Moderate. Recall number: Z-1676-2014.
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