Medtronic Neurosurgery: Medical Device Recall in 2013 - (Recall #: Z-0399-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata II Shunt Assemblies are designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart of the peritoneal cavity.

Product Classification:

Class II

Date Initiated: November 18, 2013

Date Posted: December 4, 2013

Recall Number: Z-0399-2014

Event ID: 66882

Reason for Recall:

Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the Strata II Shunt Assembly Kit because they were found to have label discrepancies.

Status: Terminated

Product Quantity: 5 units

Code Information:

Lot Numbers: D22311; D37565.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated