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# Alert on Bard’s Rotarex Atherectomy System
- URL: https://www.fdaweb.com/alert-on-bards-rotarex-atherectomy-system/
- Published: 2025-02-06T12:00:00.000Z
- Updated: 2026-09-14T14:52:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158613

FDA has issued an alert about Bard Peripheral Vascular’s Rotarex Atherectomy Systems because the helix portion of the device rotates at a high rate of speed and may be at risk of fracture or breakage when exposed to certain stress, wear, high temperatures, friction, or localized pressure. “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,” the [alert says](https://www.fda.gov/medical-devices/medical-device-recalls/early-alert-atherectomy-catheter-system-issue-bard-peripheral-vascular?ref=fdaweb.com).

A helix fracture/break could cause vessel injury and may lead to severe bleeding or death, the alert says. To date, there have been 30 serious injuries and four deaths associated with the issue. Additionally, 115 other cases required additional intervention following helix fracture/breakage.

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