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Replacement Heart-Valve
FDA product code DYE · Class 3 · Cardiovascular
203
Registered devices
37,098
Adverse events
8
Recalls
0
510(k) clearances
Devices with this code
HANCOCK II ULTRA® — MEDTRONIC, INC.CARPENTIER-EDWARDS BIOPROSTHESIS - MITRAL — Edwards Lifesciences LLCCARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT — Edwards Lifesciences LLCCARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLCHANCOCK® — MEDTRONIC, INC.HANCOCK II ULTRA® — MEDTRONIC, INC.CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL AORTIC BIOPROSTHESIS — Edwards Lifesciences LLCCARPENTIER-EDWARDS Perimount Pericardial Aortic Prosthesis — Edwards Lifesciences LLCHANCOCK® II — MEDTRONIC, INC.HANCOCK® II — MEDTRONIC, INC.CARPENTIER-EDWARDS PERIMOUNT RSRPERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLCHANCOCK® — MEDTRONIC, INC.Mosaic Neo™ 310 — MEDTRONIC, INC.HANCOCK® II — MEDTRONIC, INC.HANCOCK II ULTRA® — MEDTRONIC, INC.CARPENTIER-EDWARDS BIOPROSTHESIS - MITRAL — Edwards Lifesciences LLCHANCOCK II ULTRA® — MEDTRONIC, INC.HANCOCK® II — MEDTRONIC, INC.CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT — Edwards Lifesciences LLCCARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS - AORTIC — Edwards Lifesciences LLCHANCOCK® II — MEDTRONIC, INC.HANCOCK® II — MEDTRONIC, INC.CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS — Edwards Lifesciences LLCHANCOCK® II — MEDTRONIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-05-21 | Medtronic Inc | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger tha |
| 2019-05-21 | Medtronic Inc | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger tha |
| 2019-05-21 | Medtronic Inc | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger tha |
| 2019-05-21 | Medtronic Inc | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger tha |
| 2019-05-21 | Medtronic Inc | Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger tha |
| 2014-08-15 | Medtronic Cardiovascular Surgery-the Heart Valve Division | Medtronic has decided to discontinue production and distribution of this low-volume product. |
| 2009-01-26 | Medtronic Inc | Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed af |
| 2009-01-26 | Medtronic Inc | Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed af |
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