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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System

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  Class 2 Device Recall Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System see related information
Date Initiated by Firm April 21, 2014
Date Posted June 02, 2014
Recall Status1 Terminated 3 on October 20, 2014
Recall Number Z-1676-2014
Recall Event ID 68091
510(K)Number K031303  
Product Classification Shunt, central nervous system and components - Product Code JXG
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.
Code Information Catalog No: FV431T, FV434T, FV433T, FV459T, FV078P, FV494T, FV676T, FV324T  Lot No: 4505150452,4505156642,4505164365,4505134636,4505150384,4505156634,4505246780,4505394315,4505150371,4505174213,4505187583,4505366616,4505134635,4505187582,4505134629,4505212089,4505199667,4505150340,4505171900,4505168804  
Recalling Firm/
Manufacturer		 Aesculap, Inc.
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Customer Support
800-258-1946 Ext. 5067
Manufacturer Reason
for Recall		 AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 48
Distribution US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JXG and Original Applicant = AESCULAP, INC.
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