She died after her pacemaker failed. Its maker knew of problems for years
Key Points:
- Gladys Knepper, 93, died three weeks after her pacemaker battery failed, a malfunction linked to Boston Scientific’s Accolade pacemakers, which were recalled in December 2024 and updated in August 2025 to include 1.6 million devices.
- Boston Scientific’s pacemaker batteries, including those made after 2018, have shown high failure rates during factory tests, with FDA inspections revealing that the company did not routinely analyze test results from 2013 to 2021, contributing to delayed recognition of the problem.
- The pacemakers can enter a Safety Mode when batteries fail, designed as an emergency backup but potentially dangerous as it may stop working during physical activity; this issue has been linked to at least seven