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.
Recall
- Recall Number
- Z-1676-2014
- Event Number
- 68091
- Firm
- Aesculap, Inc.
- FEI Number
- 2916714
- Product Code
- JXG
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 21, 2014
- Posted
- June 2, 2014
- Terminated
- October 20, 2014
- Address
- 3773 Corporate Pkwy, Center Valley, PA, 18034-8217
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.
AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
Aesculap sent an Important Correction & Removal recall letter dated April 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. An Aesculap Sales Representative will contact you to schedule return of any affected inventory and replace your product. Please complete the attached Inventory Sheet which is necessary to comply with FDA regulations. When completing the inventory sheet, please be sure to fill in the quantity being returned. If you cannot locate the product, please provide an explanation as to why the inventory will not be returned (discarded, etc.). AIC (USA) appreciates your cooperation on this matter and apologizes for the inconvenience this may cause. Thank you for your patience and continued support of this product. Please contact (610) 984-9414 with any questions.
US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
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