FDA-Device2013-09-18Class II
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.
Cardiogenesis Corporation
Hazard
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
Sold states
US Distribution
Affected count
2498
Manufactured in
1655 Roberts Blvd NW, N/A, Kennesaw, GA, United States
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1993-2013Don't want to check this manually?
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