Replacement Heart-Valve
FDA adverse event reports and recall history for replacement heart-valve (product code DYE), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 36,956
- Deaths
- 1,335
- Injuries
- 34,266
- Malfunctions
- 1,272
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2019-06-26TerminatedLabeling mix-ups
Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
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.
- 2019-06-26TerminatedLabeling mix-ups
Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
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.
- 2019-06-26TerminatedLabeling mix-ups
Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
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.
- 2019-06-26TerminatedLabeling mix-ups
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
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.
- 2019-06-26TerminatedLabeling mix-ups
Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
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.
- 2014-09-11TerminatedComponent design/selection
Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
Medtronic has decided to discontinue production and distribution of this low-volume product.
- 2009-05-29TerminatedStorage
Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only; Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN 55432-5604, Manufactured at: Santa Ana, Ca. Indicated for the replacement of malfunctioning native or aortic and mitral heart valves.
Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.
- 2009-05-29TerminatedStorage
Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID , T505C2301, T505C2301, T505C2501, T505C2101, T510C29ID, T510C25ID, and T510C27ID; Sterile LC; Rx only; Medtronic Inc 710 Medtronic Parkway, Minneapolis, MN 55432-5604, Manufactured at: Santa Ana, Ca. Indicated for the replacement of malfunctioning native or aortic and mitral heart valves.
Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.
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