Every recall we track for Cardiovascular Systems Inc — 6 in all — plus the complaints and injury reports the public filed about them.
Cardiovascular Systems recalls WIRION Embolic Protection System (model WRN-D6) due to risk of device tearing during use, which could cause embolization. Affected units have specific lot numbers and UDI codes.
Cardiovascular Systems recalls STEALTH 360 GEN2 peripheral orbital atherectomy systems due to potential mislabeling of crown sizes, which could lead to incorrect use. Affected units include specific model and lot numbers.
Cardiovascular Systems recalls DIAMONDBACK 360 GEN2 peripheral orbital atherectomy systems due to potential mislabeling of crown sizes, which could lead to incorrect use in medical procedures.
Cardiovascular Systems Inc recalls CSI Orbital Atherectomy Saline Infusion Pump (SIP-3000) due to potential switch to standby mode during use requiring reset. This device is used for atherosclerotic disease treatment in patients with peripheral or coronary artery issues.
