FDA Finalizes Recall Due to Heart Devices Sending Delayed Alerts—Software Update on the Way

FDA finalizes recall due to heart devices sending delayed alerts—software update on the way

Boston Scientific is warning clinicians about an ongoing safety concern with its LUX-Dx family of insertable cardiac monitors. No devices need to be returned or replaced, but the FDA did finalize a Class II recall.

Heart Monitor Server Software Used by Boston Scientific Patients Draws Three Class 2 Recalls Over Delayed Alerts

FDA posted Class 2 recalls for Boston Scientific LUX-Dx monitor server software over delayed atrial fibrillation alerts. No injuries reported.