You need to bundle mandatory, sizable insurance as a requirement for getting the license to sell/not selling illegally (i.e., treat the device as illegal as an insurance provider who is not licensed to sell insurance, not as an unlicensed medical doctor). The insurance would make the vendor fix his shit. And he can't just chicken out. Make some way for sufficiently large companies to self-insure, or they will be mad. If they don't get mad, they probably like the reduction in competition.