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# Bard Recalls Rotarex Atherectomy Device Instructions
- URL: https://www.fdaweb.com/bard-recalls-rotarex-atherectomy-device-instructions/
- Published: 2025-03-21T12:00:00.000Z
- Updated: 2026-09-14T14:55:58.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158868

Bard Peripheral Vascular is updating the instructions for use (Class 1 recall) for its Rotarex Atherectomy Systems after receiving reports about problems occurring with the helix portion of the device because it rotates at a high rate of speed and may be at risk of fracture or breakage. “Use of the device in certain anatomy and lesion types, as well as certain procedural factors, may cause the helix to fracture or break, requiring retrieval of a broken catheter and/or device fragment,” a [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/update-alert-atherectomy-catheter-system-issue-bard-peripheral-vascular?ref=fdaweb.com) says. “A helix fracture or break could cause vessel injury and may lead to severe bleeding or death.”

To date, Bard has reported 30 serious injuries and 4 deaths associated with the issue. Additionally, Bard has reported 115 cases requiring additional intervention following helix fracture or breakage.

The system is intended for use as an atherectomy device to break up and remove thrombus from native peripheral arteries or peripheral arteries fitted with stents, stent grafts, or native or artificial bypasses.