Recall Z-1676-2014— Aesculap, Inc.

Name: FDA recall Z-1676-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-21

Class II · Terminated

Class II FDA medical device recall by Aesculap, Inc., initiated 2014-04-21, terminated 2014-10-20. It names one FDA 510(k) clearance: K031303. 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.. Reason: AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter..

Recalling firm: Aesculap, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-21
Terminated: 2014-10-20
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K031303 — AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV)Aesculap, Inc.·cleared 2003-06-04

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 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.

Reason for recall

AIC (USA) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.

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