Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.

Affected Product

The FDA is aware that Bard Peripheral Vascular, a subsidiary of Becton, Dickinson and Company (BD), has issued a letter to affected customers providing updated instructions for use for Rotarex Atherectomy Systems (as shown in Figure 1) related to a potentially high-risk device issue:

What to Do

• On February 5, 2025, BD sent all affected customers a Medical Device Correction letter recommending the following actions:
  • Review the updated electronic Instructions for Use (eIFU) for Rotarex Atherectomy System, ZE10895 revision C1 09/24, in its entirety, which can be found on BD’s website.
  • Review the updated online, on-demand training on the safe and effective use of the Rotarex Atherectomy System, reflecting the recent eIFU updates by registering on the BD Learning Academy Learning Management System. 
  • Post BD’s “Urgent: Medical Device Correction” notice with the stored product as evidence of the updated eIFU.
• BD has identified that certain patient anatomical characteristics, including vessel size, angulation, tortuosity, degree of calcification, and procedural factors such as contralateral access, sheath kinking, lack of continuous blood flow, and catheter advancement related factors, could contribute to helix fracture and/or breakage events. BD is continuing to investigate what contributing factors exist that may have resulted in reported failure and/or breakage events. Updates to the Warnings section of the eIFU for US distributed Rotarex Atherectomy Systems include:
  • Use a kink resistant, suitably reinforced sheath of the same size as the Rotarex™ Atherectomy Catheter, or 1 French size bigger. When choosing a contralateral approach this may also serve to facilitate a smooth transition across the aortic bifurcation.
    • Do not use the device across a vessel bifurcation or curve that results in a curvature of the catheter shaft of <4 cm in diameter (Figure 2). Consider the use of ipsilateral access if contralateral access is expected to result in a catheter bend less than 4 cm in diameter.
  • Maintain adequate blood flow through the catheter to reduce the risk of catheter overheating or blockage. Adequacy of blood flow can be assessed by observing continuous drainage into the collecting bag and listening for changes in the audible pitch of the motor.
  • Maintain constant catheter movement to reduce fatigue stress on the inner helix in one location. Perform a smooth back and forth motion within the target lesion. Use a 10 mm forward motion (equivalent to one catheter head) for softer materials and 1 mm for denser lesions.
    • Do not use the device in calcified vessel segments that exhibit radiopacities on both sides of the arterial wall and extend beyond 10 mm in length prior to contrast injection or digital subtraction angiography.
  • Monitor the catheter closely for resistance to movement. Audible control unit alarms (i.e., intermittent beeping) or changes in tactile feel of the catheter, pitch sound of the motor, or LED bar illumination on the control unit (where the green light is no longer illuminated, leaving only the yellow/orange light illuminated) indicate the need to reduce catheter advancement from increments of 10 mm to 1 mm, stop, or flush the catheter. 

• Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for Early Alert

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. A helix fracture or break could cause vessel injury and may lead to severe bleeding or death.

BD has reported 30 serious injuries and 4 deaths associated with this issue. Additionally, BD has reported 115 cases requiring additional intervention following helix fracture and/or breakage.

Device Use

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.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact BD’s North American Regional Complaint Center at productcomplaints@bd.com or 1-844-823-5433, saying “product complaints” when prompted.

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.  

1. Device instructions for use in U.S.
2. BD Learning Academy Learning Management System

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.