# P980043: Hancock II Porcine Bioprosthesis

- Pathway: PMA
- Applicant: Medtronic, Inc.
- Decided: Sep 28, 1999 after 334 days
- Product code: DYE (Replacement Heart-Valve)
- Device class: 3
- Regulation: 21 CFR 870.3925
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- May 21, 2019 · Class II · Z-1882-2019: 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 ja
- May 21, 2019 · Class II · Z-1884-2019: 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 ja
- May 21, 2019 · Class II · Z-1883-2019: 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 ja
- Jan 26, 2009 · Not classified · Z-1226-2009: Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding t

Source page: https://510kreport.com/device/P980043
Methodology: https://510kreport.com/methodology