Recall Z-0805-2013 ยท JXG Shunt, Central Nervous System And Components
Aesculap, Inc.
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 the peritoneum.
| Date | Feb 12, 2013 (initiated Jun 4, 2012) |
| Status | Terminated |
| Reason | The deflector may not move freely on the ventricular catheter. The deflector comes pre-positioned at the 5 cm mark on the catheter. In some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. There is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter |
| Root cause | Process control |
| Action | Aesculap sent an Important Recall Notification letter dated June 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the contact their local sales representative or customer service department at 1-800-282-9000 to return the affected product. Customers were also instructed to complete the Inventory Sheet attached to the letter with the quantity being returned. If customers could not locate the affected product they should provide an explanation as to why the inventory will not |
| Quantity | 11 |
| Distribution | Nationwide Distribution including MI, PA and TX. |
| FDA record | Open on fda.gov |