Boston Scientific knew pacemaker batteries had a critical flaw for years but delayed widespread warnings, leading to multiple deaths and injuries. Internal tests found batteries with an 'extremely high failure rate' as early as 2025, yet the company only recalled the affected devices in 2024 after Gladys Knepper's death. 1.6 million people now face risks from the Accolade pacemaker battery failure. This follows a similar 2021 recall linked to seven deaths and 800 injuries in another Boston Scientific line, Ingenio.

The company's chief medical officer acknowledged the complexity but defended its safety processes. Experts warn the system allows device makers to self-regulate recall decisions, creating a 'fox guarding the hen house' scenario where deaths may be undercounted.