PMA · Approved
Recalled · Class II · 2019Hancock II Porcine Bioprosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · DYE Replacement Heart-Valve
Approved on Sep 28, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 334-day review. It has been recalled 4 times.
- Decided
- Sep 28, 1999
- Review
- 334 days
- Class
- Class III
- Product code
- DYE
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P980043 has 78 supplements since 2002: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2002 | 2 |
| 2004 | 2 |
| 2006 | 4 |
| 2007 | 4 |
| 2008 | 2 |
| 2009 | 4 |
| 2010 | 7 |
| 2011 | 3 |
| 2012 | 3 |
| 2013 | 8 |
| 2014 | 6 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 7 |
| 2018 | 4 |
| 2019 | 3 |
| 2020 | 2 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 5 |
| 2026 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2019 | Class II | Z-1882-2019 | Labeling mix-ups | 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. |
| May 21, 2019 | Class II | Z-1884-2019 | Labeling mix-ups | 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. |
| May 21, 2019 | Class II | Z-1883-2019 | Labeling mix-ups | 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. |
| Jan 26, 2009 | Not classified | Z-1226-2009 | Storage | 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… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All DYE devicesDYE Replacement Heart-Valve: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYE
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYE
Too few DYE 510(k)s in any year since 2007 to give a median.
Recalls per year · DYE
2in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DYE
3,106in 2025
MAUDE reports naming product code DYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 28 | — | 0 | 19 |
| 2008 | 34 | — | 0 | 16 |
| 2009 | 31 | — | 2 | 910 |
| 2010 | 47 | — | 0 | 1,071 |
| 2011 | 22 | — | 0 | 1,221 |
| 2012 | 58 | — | 0 | 1,015 |
| 2013 | 66 | — | 0 | 1,219 |
| 2014 | 38 | — | 0 | 1,282 |
| 2015 | 13 | — | 0 | 1,242 |
| 2016 | 22 | — | 0 | 1,744 |
| 2017 | 34 | — | 0 | 2,284 |
| 2018 | 27 | — | 0 | 3,166 |
| 2019 | 16 | — | 0 | 2,820 |
| 2020 | 13 | — | 0 | 2,466 |
| 2021 | 7 | — | 0 | 2,833 |
| 2022 | 8 | — | 0 | 2,566 |
| 2023 | 11 | — | 0 | 3,489 |
| 2024 | 7 | — | 0 | 3,435 |
| 2025 | 13 | — | 0 | 3,106 |
| 2026 | 7 | — | 0 | — |
https://510kreport.com/device/P980043 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980043: Hancock II Porcine Bioprosthesis.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980043
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026