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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Strata II Shunt Assembly Kit

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  Class 2 Device Recall Medtronic Strata II Shunt Assembly Kit see related information
Date Initiated by Firm November 18, 2013
Date Posted November 26, 2013
Recall Status1 Terminated 3 on February 06, 2014
Recall Number Z-0399-2014
Recall Event ID 66882
510(K)Number K042465  
Product Classification Shunt, central nervous system and components - Product Code JXG
Product 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.
Code Information Lot Numbers:  D22311; D37565.
Recalling Firm/
Manufacturer		 Medtronic Neurosurgery
125 Cremona Dr
Goleta CA 93117-3083
For Additional Information Contact
805-571-8445
Manufacturer 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.
FDA Determined
Cause 2		 Other
Action Medtronic Neurosurgery sent an Urgent Medical Device Recall letter dated November 18, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to provide a copy of the letter to all those who need to be aware of the matter within their organization or to any organization where the potentially affected product may have been transferred. Customers with questions were instructed to call 805-571-8725.
Quantity in Commerce 5 units
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JXG and Original Applicant = MEDTRONIC NEUROSURGERY
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