Public recall detail

LivaNova Stöckert 3T Heater-Cooler Device - Risk of Mycobacterium chimaera Infections

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Quick summary: LivaNova Stöckert 3T Heater-Cooler Device - Risk of Mycobacterium chimaera Infections .

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Recall details

Quick summary: LivaNova Stöckert 3T Heater-Cooler Device - Risk of Mycobacterium chimaera Infections .

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Issue

Health Canada is aware of Canadian and international reports of nontuberculous mycobacteria (NTM) infections associated with the HCDs used in cardiothoracic surgery. In addressing this issue, on October 21, 2016, Health Canada issued a safety alert titled: “Important Safety Information on Heater-Cooler Devices - Risk of Nontuberculous Mycobacteria Infections”.Footnote 1 Since that time, Health Canada has continued to review available information and to work with the manufacturers of all HCDs licensed in Canada to develop strategies to further mitigate the risk of NTM infections. Evidence reviewed suggests that 3T HCDs manufactured by LivaNova prior to September 2014 are at an increased risk of contamination with M. chimaera, a type of NTM.Footnote 2 To date, cases of M. chimaera infection associated with the use of HCDs in Canada and internationally have only been reported for 3T HCDs manufactured prior to September 2014.Footnote 2

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