PMA · Approved
Recalled · Class II · 2023Matrix Vascular Closure System (VSG)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cordis US Corporation · MGB Device, Hemostasis, Vascular
Approved on Aug 17, 2005 through premarket approval, which rests on the device’s own clinical evidence after a 286-day review. It has been recalled 3 times.
- Decided
- Aug 17, 2005
- Review
- 286 days
- Class
- Class III
- Product code
- MGB
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P040044 has 107 supplements since 2007: 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 |
|---|---|
| 2007 | 4 |
| 2008 | 5 |
| 2009 | 13 |
| 2010 | 10 |
| 2011 | 5 |
| 2012 | 4 |
| 2013 | 5 |
| 2014 | 10 |
| 2015 | 8 |
| 2016 | 6 |
| 2017 | 3 |
| 2018 | 5 |
| 2019 | 3 |
| 2021 | 5 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 11 |
| 2025 | 2 |
| 2026 | 2 |
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 |
|---|---|---|---|---|
| Nov 28, 2023 | Class II | Z-0674-2024 | Labeling Change Control | Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F)… |
| Nov 28, 2023 | Class II | Z-0675-2024 | Labeling Change Control | Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two lots of MynxGrip. The carton box from lot F2322902 (Item MX5021, MynxGrip 5F) as labeled as lot F2322903 (MX6721, MynxGrip 6/7F)… |
| Jul 13, 2016 | Class II | Z-2329-2016 | Process control | A total of 70 6F/7F Mynx Grip devices were shipped from a distributor using improper transport/packaging configurations. |
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/P040044 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040044: Matrix Vascular Closure System (VSG).” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040044
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026