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

    • 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
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 2, 2017 · Data as of Sep 19, 5:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.