Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated Recalled by Cardiogenesis Corporation Due to Following acquisition of Cardiogenesis, we began receiving complaints...
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 Cardiogenesis Corporation directly.
Affected Products
Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of patients with angina (Canadian Cardiovascular Society Class 4) refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.
Quantity: 2498
Why Was This Recalled?
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
Where Was This Sold?
US Distribution
About Cardiogenesis Corporation
Cardiogenesis Corporation has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report