FDA Enforcement
Class II
Terminated
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.
Recall: Z-1993-2013
·
Reported September 18, 2013
Enforcement
- Recall Number
- Z-1993-2013
- Event ID
- 66046
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cardiogenesis Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 18, 2013
- Initiation Date
- May 1, 2011
- Classification Date
- September 11, 2013
- Termination Date
- September 15, 2014
- Address
- 1655 Roberts Blvd NW, N/A, Kennesaw, GA, 30144-3632, United States
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
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
Code Info
Product Code - HP-SG3 Product Code -HP-PRL5
Distribution
US Distribution
Quantity
2498