Arguing that medical devices don't fail is specious. The procedure for reporting errors that lead to deaths can be found here: https://www.fda.gov/MedicalDevice

Arguing that medical devices don't fail is specious. The procedure for reporting errors that lead to deaths can be found here: https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm https://www.fda.gov/MedicalDevices/Safety/ReportaProblem/def... > "Each year, the FDA receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries and malfunctions." It is also specious to argue that a consumer product is being used for live surgeries without FDA approval. This does not excuse the mistake, nor does it change the fact that the error will make people question the reliability of the product - as they should. However, mistakes do happen, even big ones. Rockets blow up. Airbags have defects that make them not work. McAfee pushed out an antivirus update that deleted a Windows system file, crashing hundreds of thousands of PCs. The important questions are: how does the vendor respond, what procedures do they put into place to prevent it from happening again, and are those procedures enough to give future buyers confidence that the issues are addressed? Saying "that shouldn't have happened," while perhaps true, is simply not constructive.