Elana Recalls
2 recalls on record · April 24, 2013 to December 14, 2016 · Medical Devices
Recalls by year
13
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 14, 2016Medical DevicesFDA
Elana, Inc. recalls Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300
Hazard: Elana has issued this Field Action to voluntarily remove specific serial numbers of our Elana Surgical KitHUD due to potentially compromised integrity of the outer sterile packaging of the Elana Catheter 2.0.
April 24, 2013Medical DevicesFDA
Elana, Inc. recalls Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of
Hazard: Distribution of an unapproved device into interstate commerce.