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Cardiogenesis Corporation recalls Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of
Recalled September 18, 2013 · FDA recall Z-1993-2013 · Cardiogenesis
Hazard
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces. · FDA Class II
Units
2498
Sold at
US Distribution
Description
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
Product
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.
Manufacturer(s)
Cardiogenesis Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →