CLASS II Device recall · Reported 8 Feb 2017 · FDA Enforcement Report
Medtronic Strata II / Strata NSC Valves recalled
Medtronic Neurosurgery is recalling Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal, distributed nationwide in the US. The recall was initiated on 17 Jan 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1121-2017
- FDA event ID
- 76249
- Recalling firm
- Medtronic Neurosurgery, Goleta, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Jan 2017
- FDA classified
- 2 Feb 2017
- Reported
- 8 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 17 Jan 2017 | Recall initiated by company | |
| 2 Feb 2017 | Classified by FDA | +16 days |
| 8 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
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
Questions about this recall
Why was it 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.
Which lots are affected?
All Lot Numbers
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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