Device 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.
Z-1993-2013
Product summary
- Event
- Event 66046
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2498
- Official record key
device-enforcement:Z-1993-2013
Official wording
Reason: Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
Code information: Product Code - HP-SG3 Product Code -HP-PRL5
Distribution pattern: US Distribution
Derived failure modes
-
Unknown
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.