Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for u...
FDA Recall #Z-1993-2013 — Class II — May 1, 2011
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.
Recalling Firm
Cardiogenesis Corporation — Kennesaw, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2498
Distribution
US Distribution
Code Information
Product Code - HP-SG3 Product Code -HP-PRL5
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated