Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
CSI Recalled by Cardiovascular Systems, Inc. Due to Cardio vascular Systems Inc. has initiated a recall...
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, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-02, Model Number DBEC-125 Product Usage: The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
Quantity: 318
Why Was This Recalled?
Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C
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