FDAFDA · Food and drugs·Recall number Z-1993-2013
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.
Published September 18, 2013 · Recall initiated: May 1, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cardiogenesis Corporation
- Distributor
- US Distribution
- Lot
- Product Code - HP-SG3 Product Code -HP-PRL5
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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