Aesculap, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0989-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.
Product Description:

Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

Product Classification:

Class II

Date Initiated: December 23, 2013
Date Posted: February 26, 2014
Recall Number: Z-0989-2014
Event ID: 67174
Reason for Recall:

The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.

Status: Terminated
Product Quantity: 79
Code Information:

4 lots: 4505268906, 4505336973, 4505408485, 4505238953

Distribution Pattern:

Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.

Voluntary or Mandated:

Voluntary: Firm initiated