FDA Issues Early Alert About Risks of Peripheral Atherectomy Device

The US Food and Drug Administration is alerting the public of a potentially high-risk device issue related to Rotarex Atherectomy Systems (Bard Peripheral Vascular) used in peripheral artery interventions.

On February 5, 2025, Bard Peripheral Vascular issued a Medical Device Correction letter to customers regarding a possible problem related to the helix portion of the atherectomy system, which rotates at a high speed. The device is intended for use in PAD lesions, including in-stent restenosis, to aid in removing both plaque and thrombus.

“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 helix fracture or break could cause vessel injury and may lead to severe bleeding or death,” the FDA notes in their “early alert.”

The agency adds that the company has reported 30 serious injuries and four deaths associated with this issue. There also have been 115 cases in which additional intervention was required after a helix fractured and/or broke during a procedure.

The Medical Device Correction letter gives updated instructions for using the 6-Fr and 8-Fr Rotarex systems and refers customers to the manufacturer’s online learning portals for more recommendations on safe use of the device.