FDA Class I Recall of Bard Peripheral Vascular’s Rotarex Atherectomy System
FDA Class I Recall of Bard Peripheral Vascular’s Rotarex Atherectomy System
Highlighted by AHA , March 21, 2025
1. Recall Classification and Reason
• The FDA has classified the recall as Class I, the most serious type, due to risks of serious injury or death.
• The recall affects multiple models of Bard Peripheral Vascular’s Rotarex Atherectomy System.
• Issue: The helix portion of the device may fracture or break off during use, potentially leading to:
• Vessel injury
• Severe bleeding
• Need for additional interventions
• Death
2. Reported Adverse Events
• 115 cases required additional intervention.
• 30 serious injuries reported.
• 4 patient deaths linked to device failure.
3. FDA Actions & Updated Usage Instructions
• Devices are NOT being removed from the market but must be used following updated Instructions for Use (IFU).
• Key safety measures include:
• Use a kink-resistant sheath of the same or slightly larger size.
• Avoid use in vessels with sharp curves (diameter <4 cm).
• Ensure continuous blood flow to prevent overheating or blockage.
• Maintain constant movement to reduce stress on the helix.
• Avoid calcified vessel segments longer than 10 mm.
• Monitor for resistance, alarms, or motor pitch changes as signs to stop or flush the catheter.
For more details, refer to the FDA and Bard Peripheral Vascular’s official advisory.
