Bengaluru: Boston Scientific has issued an urgent recall to correct several heart devices after the U.S. Food and Drug Administration classified the action as its most serious recall, the regulator said on Thursday.
The recall does not require the devices to be removed from patients or pulled from sale. Instead, doctors are being told to update the devices’ software during an in-person clinic visit, the FDA said.
The FDA said continued use without the correction could lead to serious injury or death.
As of March 18, 2026, Boston Scientific had reported four deaths and 2,557 serious injuries linked to the issue.
The affected devices include Accolade, Essentio, Proponent, Altrua 2, Valitude and Visionist pacemakers and cardiac resynchronization therapy pacemakers.
Boston Scientific has advised that all affected devices be upgraded with new software known as Brady SMR6.
The FDA said the software update is meant to fix problems caused by an earlier Boston Scientific update.
The agency said Boston Scientific is also developing another software update and revised instructions to address a battery issue.
Doctors are being advised to promptly schedule in-person follow-up for some higher-risk patients, including those who depend on the device and have limited battery life remaining. Routine follow-up is recommended for other patients.
(Reporting by Padmanabhan Ananthan in Bengaluru; Editing by Tasim Zahid)
