Medtronic Neurosurgery: Medical Device Recall in 2013 - (Recall #: Z-0397-2014)

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:

CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, Catalog No. 46026. CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity.

Product Classification:

Class II

Date Initiated: November 18, 2013

Date Posted: December 4, 2013

Recall Number: Z-0397-2014

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: 288 units total (147 units in US)

Code Information:

Lot Numbers: Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539. Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540. Catalog No. 46026: D35572; D39583.

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