Class 2 Device Recall Strata II / Strata NSC valves

• Date Initiated by Firm: January 17, 2017
• Date Posted: February 02, 2017
• Recall Status: Terminated on June 02, 2017
• Recall Number: Z-1121-2017
• Recall Event ID: 76249
• 510(K)Number: K033850 K060681 K042465 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: 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

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