Safety update: FDA announces Class I recall due to atherectomy devices breaking during use

Bard Peripheral Vascular Rotarex Atherectomy System recall

Bard Peripheral Vascular's Rotarex Atherectomy System. Image courtesy of Bard Peripheral Vascular and BD.

The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.