A medical device manufacturer has issued an urgent recall to correct several types of heart devices after the Food and Drug Administration (FDA) classified the action as its most serious type of recall, the agency said in a notice on Thursday.
The recall does not require the devices to be removed from patients' bodies or from where they are sold, according to the notice. Doctors are being told by the recalling company, Boston Scientific, that they need to update the devices' software during an in-person visit.
The FDA warned that the continued use of the devices without the update could lead to "serious injury or death." As of mid-March 2026, the company reported four deaths and 2,557 serious injuries connected to the problem.
The notice added that the software update is meant to fix problems caused by an earlier Boston Scientific update. 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.
The agency said Boston Scientific is also creating another software update and will issue revised instructions to address a battery problem with the devices.
"Consult with your health care provider if you have new or worsening symptoms such as lightheadedness or loss of consciousness, or questions about your device potentially entering Safety Mode," the FDA said in its warning on Thursday.
The notice also said the correction involves an earlier update of the heart devices, issued in March 2026.
Multiple warnings have been issued about Boston Scientific pacemaker recalls over the past year and a half due to injuries associated with its devices. The company first initiated its recall of multiple pacemakers starting on Dec. 16, 2024, because the devices have "an increased risk to permanently enter Safety Mode, which has limited functionality and has been associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients," the FDA said.
The recall comes in the midst of lawsuits being filed over alleged defects to pacemakers and other heart devices. In January, a woman filed a lawsuit against pacemaker manufacturer Medtronic, claiming that a defective Azure dual-chamber pacemaker caused dangerous heart issues, forcing her to undergo surgery to remove and replace the device.
Boston Scientific did not immediately respond to a request for comment on Friday.