Update: FDA says St. Jude Medical knew about Device Flaws 2 Years Before Muddy Waters Report

The FDA issued a warning to Abbott/St. Jude Medical after finding the company was aware since 2014 of exploitable software vulnerabilities (notably a hard-coded universal unlock code) and battery defects in implantable cardiac devices, failed to adequately assess and mitigate those risks, and continued distribution—issues tied to at least one patient death and resulting in regulatory demands to remediate security and reliability problems before further Class III device approvals.