|
Early Alert: Atherectomy Catheter System Issue from Bard Peripheral Vascular
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 related to a potentially high-risk device issue.
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.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.
Questions?
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.
|
