Medtronic Strata II / Strata NSC Valves (includes Burr Hole… recallZ-1121-2017 · Medtronic Neurosurgery · initiated Jan 17, 2017
Class II Terminated All recalls posted in February 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neurosurgery or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Other
What the company is doing
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..
Recall details
- Recall number
- Z-1121-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 17, 2017
- Posted by the FDA
- Feb 2, 2017
- Recalling firm
- Medtronic Neurosurgery
- Quantity
- 315,997
- Product code
- JXG
- FDA submissions
- K033850, K042465, K060681, K082127
- 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
Product description
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 (models, lots, serial numbers)
All Lot Numbers
Other devices under the same FDA submission
48 devices cleared under K033850, K042465, K060681, K082127 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death160 reports
- Strata® 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components1 death75 reports
- Strata™ 42866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components56 reports
- Strata® 27819Medtronic Ps Medical, Inc. · Shunt, central nervous system and components38 reports
- Strata™ 42856Medtronic Ps Medical, Inc. · Shunt, central nervous system and components31 reports
- Strata® 42856Medtronic Ps Medical, Inc. · Shunt, central nervous system and components30 reports
- Strata® 42856Medtronic Ps Medical, Inc. · Shunt, central nervous system and components20 reports
- Strata™ 92866Medtronic Ps Medical, Inc. · Shunt, central nervous system and components14 reports
- Strata® 42365Medtronic Ps Medical, Inc. · Shunt, central nervous system and components12 reports
- Strata®, BioGlide® 27819Medtronic Ps Medical, Inc. · Shunt, central nervous system and components11 reports
- Strata® 42365Medtronic Ps Medical, Inc. · Shunt, central nervous system and components9 reports
- Delta® 25131-5Medtronic Ps Medical, Inc. · Shunt, central nervous system and components9 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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