Reported Feb 8, 2017 · Terminated
Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Peritoneal. All Catalog Numbers. Strata-type…
Medtronic Neurosurgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neurosurgery · 125 Cremona Dr · Goleta, CA · 93117-3083
Is this the product you have?
- 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.
69 of 69 codes
277392774027786277872778827789277942781227814278152781627817278182782027821278222782327824278252782727828278302783127832278482786427867278682788827903279222782327924230422792527926279272793227933423354235542365428364285642866444204442144430444654607046075460804608546635466554666546836468564686646871
- Lot codes and dates
- All Lot Numbers
- Amount recalled
- 315,997
Where it was sold
- Nationwide
- PR
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.
This product could cause temporary or reversible health problems — stop using it.
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