Date Initiated by Firm | January 17, 2017 |
Date Posted | February 02, 2017 |
Recall Status1 |
Terminated 3 on June 02, 2017 |
Recall Number | Z-1121-2017 |
Recall Event ID |
76249 |
510(K)Number | K033850 K042465 K060681 K082127 |
Product Classification |
Shunt, central nervous system and components - Product Code JXG
|
Product | Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers.
Strata-type valves are used in the management of hydrocephalus. The Strata II/Strata NSC valve is a shunt component designed to allow for continuous flow of cerebrospinal fluid (CSF) from the ventricles of the brain to the peritoneal cavity or right atrium of the heart. mechanism.
Strata Valve Magnet Reverse Polarity (Excludes StrataMR).
Catalog No.
27739
27740
27786
27787
27788
27789
27794
27812
27814
27815
27816
27817
27818
27820
27821
27822
27823
27824
27825
27827
27828
27830
27831
27832
27848
27864
27867
27868
27888
27903
27922
27823
27924
23042
27925
27926
27927
27932
27933
42335
42355
42365
42836
42856
42866
44420
44421
44430
44465
46070
46075
46080
46085
46635
46655
46665
46836
46856
46866
46871
46876
46881
46886
92355
92365
92856
92866
96655
96665 |
Code Information |
All Lot Numbers |
Recalling Firm/ Manufacturer |
Medtronic Neurosurgery 125 Cremona Dr Goleta CA 93117-3083
|
For Additional Information Contact | 805-571-8400 |
Manufacturer Reason for Recall | Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between February 15, 2015 and August 23, 2016 reporting of discrepancies between the pressure/performance level (PL) at which the valve was set and the readings determined via an x-ray image. |
FDA Determined Cause 2 | Other |
Action | Medtronic sent an Urgent Product Advisory Notice dated January 19, 2017, was sent to customers to inform them that Medtronic Neurosurgery is initiating a voluntary field corrective action (FCA) for the Medtronic Strata II / Strata NSC valves (includes Burr Hole and Lumboperitoneal. Excludes StrataMR). Medtronic is notifying healthcare providers of an Instructions For Use (IFU) Warning update for the affected products by sending a Product Advisory Notice.
For further questions regarding this recall please call (805) 571-8400.. |
Quantity in Commerce | 315,997 |
Distribution | Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of :
Algeria
India
Poland
Armenia
Indonesia
Portugal
Australia
Iran
Austria
Iraq
Qatar
Bangladesh
Ireland
Republic of Montenegro
Barbados
Israel
Republic of Serbia
Belarus
Italy
Romania
Belgium
Jamaica
Russian Federation
Bosnia and Herzegovina
Japan
Saudi Arabia
Botswana
Jordan
Singapore
Bulgaria
Kazakhstan
Slovakia
Cambodia
Kenya
South Africa
Canada
Kuwait
South Korea
Canary Islands
Latvia
Spain
Cayman Islands
Lebanon
Sri Lanka
China
Libya
Sweden
Croatia
Lithuania
Switzerland
Cyprus
Macau
Syria |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JXG
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