Reported Sep 18, 2013 · Terminated
Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device is indicated for use in the treatment of…
Cardiogenesis Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardiogenesis Corporation · 1655 Roberts Blvd NW · Kennesaw, GA · 30144-3632
Is this the product you have?
- 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.
- Lot codes and dates
- Product Code - HP-SG3 Product Code -HP-PRL5
- Amount recalled
- 2498
Why it was recalled
Following acquisition of Cardiogenesis, we began receiving complaints of sparks, burns, or smoke incidents related to the handpieces.
This product could cause temporary or reversible health problems — stop using it.
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