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HANCOCK®
MEDTRONIC, INC. · Model HC105-14 · UDI-DI 00681490908504
DYE
Prescription
0
510(k) clearances
37,098
Adverse events (1,336 deaths)
8
Recalls
13
Facilities
Description
CONDUIT HC105-14 HKI LOW POROSITY 10L
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 than what was indicated |
| 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 than what was indicated |
| 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 than what was indicated |
| 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 than what was indicated |
| 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 than what was indicated |
| 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 after exposure to temp |
| 2009-01-26 | Medtronic Inc | Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temp |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.