Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CSI Stealth 360-degree Orbital Atherectomy Device (OAD) Recalled by Cardiovascular Systems, Inc. Due to CSI has initiated a recall on specific lot...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cardiovascular Systems, Inc. directly.
Affected Products
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.
Quantity: 27
Why Was This Recalled?
CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report