Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM Recalled by Cardiovascular Systems Inc Due to Mislabeling
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
STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO
Quantity: 8 units
Why Was This Recalled?
There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cardiovascular Systems Inc
Cardiovascular Systems Inc has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report