System, Laser, Transmyocardial Revascularization
FDA adverse event reports and recall history for system, laser, transmyocardial revascularization (product code MNO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 154
- Deaths
- 8
- Injuries
- 57
- Malfunctions
- 82
Reports per year
Source: FDA adverse event reports by year received, 1998–2022. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2013-09-11TerminatedDevice Design
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.
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