FDA-Device2014-02-12Class II
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Medtronic Cardiovascular Surgery-the Heart Valve Division
Hazard
Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator Model 7305 used with the Mosaic Porcine Aortic Bioprosthesis, Model Number 305, because of higher-than-expected transvalvular gradients occurring post implant.
Sold states
Worldwide Distribution - USA (nationwide)
Affected count
8276 units
Manufactured in
1851 E Deere Ave, Santa Ana, CA, United States
Products
Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0908-2014Don't want to check this manually?
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