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
- Recall Number
- Z-1993-2013
- Event Number
- 66046
- Firm
- Cardiogenesis Corporation
- FEI Number
- 3001451326
- Product Code
- MNO
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 1, 2011
- Posted
- September 11, 2013
- Terminated
- September 15, 2014
- Address
- 1655 Roberts Blvd NW, Kennesaw, GA, 30144-3632
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.
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
Cardiogenesis is responsible for the correction of all noncompliant products. CDRH understands that the corrective action plan (CAP), involving 2,437 Sologrip III handpieces and 61 PEARL 5.0 handpieces, consists of the following: 1. Notification to purchasers of the handpiece removal and replacement procedures, 2. Replace existing hospital inventory of handpieces with a redesigned handpiece CDRH approves the CAP subject to the following conditions: 1. Notification of all distributors and purchasers will be successfully implemented, and 2. Corrections will be made at no cost to the purchasers by October 1, 2013. For further questions please call (949) 420-1800.
US Distribution
2498