PMA · Approved
Recalled · Class II · 2023Vascular Solutions Duett Sealing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · MGB Device, Hemostasis, Vascular
Approved on Jun 22, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 358-day review. It has been recalled once.
- Decided
- Jun 22, 2000
- Review
- 358 days
- Class
- Class III
- Product code
- MGB
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P990037 has 31 supplements since 2001: 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 |
|---|---|
| 2001 | 6 |
| 2002 | 4 |
| 2003 | 7 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 2 |
| 2016 | 2 |
| 2021 | 1 |
| 2022 | 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 MGB? 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 |
|---|---|---|---|---|
| Apr 12, 2023 | Class II | Z-1611-2023 | Under Investigation by firm | The product contains an expired diluent vial. If the impacted product is used, the sterility of the diluent component cannot be assured as it has passed beyond the studied shelf life of the product. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MGB devicesMGB Device, Hemostasis, Vascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGB
18in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MGB
Too few MGB 510(k)s in any year since 2007 to give a median.
Recalls per year · MGB
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGB
12,664in 2025
MAUDE reports naming product code MGB, 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 | 18 | — | 0 | 1,588 |
| 2008 | 20 | — | 0 | 2,267 |
| 2009 | 34 | — | 1 | 2,436 |
| 2010 | 22 | — | 0 | 3,933 |
| 2011 | 23 | — | 0 | 4,011 |
| 2012 | 16 | — | 1 | 3,786 |
| 2013 | 12 | — | 0 | 3,011 |
| 2014 | 26 | — | 0 | 4,468 |
| 2015 | 28 | — | 0 | 3,944 |
| 2016 | 26 | — | 0 | 4,330 |
| 2017 | 15 | — | 0 | 5,346 |
| 2018 | 23 | — | 0 | 5,679 |
| 2019 | 27 | — | 0 | 6,156 |
| 2020 | 10 | — | 0 | 5,927 |
| 2021 | 17 | — | 0 | 7,586 |
| 2022 | 11 | — | 0 | 9,457 |
| 2023 | 18 | — | 2 | 13,529 |
| 2024 | 22 | — | 0 | 13,762 |
| 2025 | 18 | — | 0 | 12,664 |
| 2026 | 24 | — | 0 | — |
https://510kreport.com/device/P990037 · printed Nov 6, 2026
Cite this page
510(k) Report. “P990037: Vascular Solutions Duett Sealing Device.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P990037
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026