The FDA has issued a Class I recall for the CardioTrack Pro implantable cardiac monitor manufactured by MedPulse Devices after reports of premature battery depletion in 23 units. The device is used to continuously monitor heart rhythm in patients with atrial fibrillation and unexplained stroke.
Approximately 15,000 devices have been implanted in patients across the United States since the product's launch in 2024. MedPulse is advising physicians to schedule check-ups for all patients with the device to verify battery status and functionality.
The FDA emphasizes that patients should not attempt to remove or modify the device on their own and should contact their healthcare provider if they experience symptoms such as dizziness or irregular heartbeat that could indicate monitoring gaps.
