Recall Z-0805-2013— Aesculap, Inc.

Name: FDA recall Z-0805-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-04

Class II · Terminated

Class II FDA medical device recall by Aesculap, Inc., initiated 2012-06-04, terminated 2014-01-08. It names 2 FDA 510(k) clearances: K110206, K020728. Product: 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.. 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.

Recalling firm: Aesculap, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-06-04
Terminated: 2014-01-08
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

2 on FDA's record

K110206 — AESCULAP- MEITHKE SHUNT SYSTEMAesculap, Inc.·cleared 2011-10-27
K020728 — MIETHKE SHUNT SYSTEMAesculap, Inc.·cleared 2002-04-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.