Recall Z-0398-2014— Medtronic Neurosurgery

Name: FDA recall Z-0398-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-18

Class II · Terminated

Class II FDA medical device recall by Medtronic Neurosurgery, initiated 2013-11-18, terminated 2014-02-06. It names one FDA 510(k) clearance: K902783. Product: Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.. Reason: 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..

Recalling firm: Medtronic Neurosurgery
Classification: Class II
Status: Terminated
Initiated: 2013-11-18
Terminated: 2014-02-06
Firm location: Goleta, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K902783 — PS MEDICAL DELTA CSF-FLOW CONTROL VALVEPudenz-Schulte Medical Research Corp.·cleared 1990-08-08

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

Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0, Catalog No. 276201. Delta Shunt Assemblies are designed for use in shunting CSF from the lateral ventricle of the brain into the peritoneal cavity.

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.

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