Boston Scientific issues software correction for 3,592 pacemakers and cardiac devices
The FDA says Boston Scientific has opened a worldwide correction for software used in certain ACCOLADE-family pacemakers and CRT-P devices.
Boston Scientific has initiated a software correction for 3,592 pacemakers and cardiac-resynchronization devices after the U.S. Food and Drug Administration identified a risk involving Safety Mode, battery-impedance readings and some patients using the company’s LATITUDE monitoring system.
The FDA’s medical-device recall record was updated July 26, 2026. It describes the correction as applying to certain ACCOLADE-family devices distributed worldwide. The record is open and classified, and identifies Boston Scientific Corporation as the recalling firm.
The correction is intended to reduce the risk that an affected device enters Safety Mode in an ambulatory setting because of high battery impedance. The record does not say that every listed device has failed, and it does not establish how many U.S. patients are affected.
Devices covered by the correction
The affected product family includes ACCOLADE, PROPONENT, ESSENTIO and ALTRUA 2 pacemakers. It also includes Boston Scientific’s VISIONIST and VALITUDE CRT-P devices.
The listed quantity in commerce is 3,592 units. That is a worldwide figure, not a count of devices or patients in the United States. The FDA record identifies worldwide distribution and provides U.S. technical-support information, making the issue relevant to patients and clinicians across the country.
What the software issue can do
According to the FDA record, the correction addresses a potential false-positive response during daily battery testing when a magnet is present. Under the described conditions, the device’s response could lead to Safety Mode initiation while the patient is away from a clinical setting.
Safety Mode is a device operating state referenced in the FDA record. The approved information does not provide additional clinical details about the mode, and it does not state that the issue has caused an injury or death.
The correction also has implications for patients enrolled in Boston Scientific’s LATITUDE monitoring system. The FDA says LATITUDE-monitoring patients may receive an erroneous explant indicator and may lose LATITUDE availability until the issue is addressed.
In practical terms, that means a patient or care team could see an incorrect signal suggesting that a device should be removed or replaced, or could experience a temporary loss of remote monitoring availability. The record does not provide a patient-specific interpretation of any indicator. Device-specific instructions must come from the manufacturer’s advisory and the treating clinical team.
What patients and clinicians should know
The FDA record identifies a software-management issue affecting implanted cardiac devices, rather than announcing that all devices in the listed families have malfunctioned. It also does not direct patients to stop using or remove their devices without physician guidance.
Patients and clinicians with one of the listed device models need the Boston Scientific advisory for instructions specific to the device and the patient’s circumstances. The approved FDA record does not identify how many devices are in the United States, report whether anyone has been injured or killed, or provide a public deadline for completing the correction.
The FDA record remains open and classified. The known next step is device-specific follow-up through Boston Scientific’s advisory and technical-support process, with clinicians and patients verifying whether the correction applies and how it should be managed.
Sources
- Medical Device Recall: Boston Scientific ACCOLADE-family software correction, U.S. Food and Drug Administration
- Medical Device Safety, U.S. Food and Drug Administration
