Recall Z-1993-2013— Cardiogenesis Corporation
Class II · Terminated
Class II FDA medical device recall by Cardiogenesis Corporation, initiated 2011-05-01, terminated 2014-09-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces..
- Recalling firm
- Cardiogenesis Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-05-01
- Terminated
- 2014-09-15
- Firm location
- Kennesaw, GA, United States
Product description
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.
Reason for recall
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
Data sourced from openFDA. This site is unofficial and independent of the FDA.