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.

Sep 4, 2026 - 01:00
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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.

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