Recall Background
Health Canada initiated the Class II recall of the CardioSync 7 Ambulatory Cardiac Monitor following eight Medical Device Problem Reports submitted between May and June 2026. Each report described episodes where the device failed to record ECG segments during periods of patient physical activity above a threshold equivalent to moderate walking pace, attributed to a firmware defect in the motion-artefact filtering algorithm introduced in firmware version 3.1.4.
Scope and Affected Devices
The recall covers all CardioSync 7 devices running firmware versions 3.1.4, 3.1.5, and 3.1.6, distributed to Canadian cardiac clinics and hospitals between November 2025 and June 2026. Approximately 2,800 devices are affected. Devices running firmware 3.1.3 or earlier, or 3.2.0 or later (which incorporates the corrected algorithm), are not subject to the recall.
Clinical Risk Assessment
The Class II designation reflects Health Canada's assessment that the probability of serious adverse health consequences is remote. However, the agency noted that missed arrhythmia recordings could potentially lead to delayed diagnosis in patients being monitored for paroxysmal atrial fibrillation or ventricular ectopy. Clinicians are advised to review monitoring periods for affected patients and consider repeat studies where clinically indicated.
Corrective Actions
The manufacturer is offering remote over-the-air firmware update to version 3.2.0 for devices with cellular connectivity. Devices without cellular capability must be returned to service centres for firmware update. The manufacturer has committed to completing all updates within 30 days of recall initiation and will provide Health Canada with weekly update completion reports.