FDA Device recall Z-1993-2013
Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser
- FDA Device
- Class II
- terminated
- Published 2013-09-18
On 2013-09-18 the FDA classified a Class II recall of Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser by Cardiogenesis, citing following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1993-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2011-05-01 |
| Published | 2013-09-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cardiogenesis |
| Distribution | n/a |
Product
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.
Identifiers
| code_info | Product Code - HP-SG3 Product Code -HP-PRL5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1993-2013%22
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