FDA-Device2019-07-03Class II
Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Medtronic Inc
Hazard
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Sold states
Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.
Affected count
1 unit
Manufactured in
710 Medtronic Pkwy Mailstop Ls245, N/A, Minneapolis, MN, United States
Products
Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1881-2019Don't want to check this manually?
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