Device Recall Stealth 360degree Obital Atherectomy Device

Lot s: 59887, 59888, 61516, and 61517.

Cardiovascular Devices

2

No

Nationwide distribution including CA, FL, IL, MI, MN, PA, and TX.

CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11, Model Number PRD-SC30-125S. Sterilized with Ethylene Oxide. The Stealth 360-degree Orbital Atherectomy Device (OAD) is part of the Stealth 360-degree Orbital PAD system. || The Stealth 360-degree Orbital PAD system is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.