Recall Z-1676-2014 ยท JXG Shunt, Central Nervous System And Components
Aesculap, Inc.
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.
| Date | Jun 2, 2014 (initiated Apr 21, 2014) |
| Status | Terminated |
| Reason | AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter. |
| Root cause | 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 inv |
| Quantity | 48 |
| Distribution | US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031303 | AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) Aesculap, Inc., Jun 4, 2003 |