Implanting a Recalled Device — Choices for Patients, Physicians, and Public Health

This NEJM Perspective explores ethical, regulatory, and clinical implications of implanting implantable cardioverter-defibrillators (ICDs) subject to active Class I recalls due to rare but serious malfunctions. Medtronic issued advisories in 2022 and 2023 for specific ICD models with risks of reduced- or no-energy shocks stemming from short-circuit detection errors and defective glassed feedthroughs. Despite software updates and programming recommendations (e.g. AX->B to B->AX polarity), device replacement isn't mandated, and some centers continue to implant affected models. Authors advocate (1) an independent, multistakeholder study to quantify device failure risks; (2) quarterly performance updates from manufacturers; and (3) informed decision-making, including preprocedure counseling about malfunction risks. They emphasize transparency, independent scientific validation, and careful manufacturer–regulator–physician coordination to uphold patient safety while retaining access to lifesaving technologies.

This NEJM Perspective explores ethical, regulatory, and clinical implications of implanting implantable cardioverter-defibrillators (ICDs) subject to active Class I recalls due to rare but serious malfunctions. Medtronic issued advisories in 2022 and 2023 for specific ICD models with risks of reduced- or no-energy shocks stemming from short-circuit detection errors and defective glassed feedthroughs. Despite software updates and programming recommendations (e.g. AX->B to B->AX polarity), device replacement isn't mandated, and some centers continue to implant affected models. Authors advocate (1) an independent, multistakeholder study to quantify device failure risks; (2) quarterly performance updates from manufacturers; and (3) informed decision-making, including preprocedure counseling about malfunction risks. They emphasize transparency, independent scientific validation, and careful manufacturer–regulator–physician coordination to uphold patient safety while retaining access to lifesaving technologies.