“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
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
Description du dispositif
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