Z-1993-2013 Class II Terminated
FDA device recall Z-1993-2013 was initiated by Cardiogenesis Corporation on May 1, 2011 and is designated Class II. Reason for recall: Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces. The recall status is terminated (terminated September 15, 2014). Affected quantity: 2498.
Recall Details
- Product Type
- Devices
- Report Date
- September 18, 2013
- Initiation Date
- May 1, 2011
- Termination Date
- September 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2498
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.
Distribution Pattern
US Distribution
Code Information
Product Code - HP-SG3 Product Code -HP-PRL5