PMA · Approved
Recalled · 2004Express/Express 2 MR & Otw Coronary Stent Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · MAF Stent, Coronary
Approved on Sep 11, 2002 through premarket approval, which rests on the device’s own clinical evidence after a 180-day review. It has been recalled 3 times.
- Decided
- Sep 11, 2002
- Review
- 180 days
- Class
- Class III
- Product code
- MAF
- Recalls
- 3
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020009 has 120 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 |
| 2003 | 9 |
| 2004 | 4 |
| 2005 | 5 |
| 2006 | 9 |
| 2007 | 5 |
| 2008 | 8 |
| 2009 | 9 |
| 2010 | 9 |
| 2011 | 15 |
| 2012 | 22 |
| 2013 | 9 |
| 2014 | 13 |
| 2016 | 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 MAF? 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 |
|---|---|---|---|---|
| Jul 16, 2004 | Not classified | Z-1121-04 | Other | Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure. |
| Jul 16, 2003 | Not classified | Z-1123-03 | Other | There is an Increased potential for broken struts of the stents. |
| Mar 20, 2003 | Not classified | Z-0711-03 | Other | The product units in the recalled lot were in pouches which could have incomplete seals that could lead to compromised sterility. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MAF devicesMAF Stent, Coronary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAF
Too few MAF 510(k)s in any year since 2007 to give a median.
Recalls per year · MAF
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAF
111in 2025
MAUDE reports naming product code MAF, 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 | 34 | — | 1 | 1,201 |
| 2008 | 41 | — | 1 | 1,288 |
| 2009 | 36 | — | 5 | 1,370 |
| 2010 | 55 | — | 0 | 1,568 |
| 2011 | 67 | — | 0 | 1,233 |
| 2012 | 77 | — | 0 | 1,053 |
| 2013 | 41 | — | 0 | 1,049 |
| 2014 | 53 | — | 0 | 876 |
| 2015 | 22 | — | 0 | 664 |
| 2016 | 26 | — | 0 | 696 |
| 2017 | 35 | — | 0 | 695 |
| 2018 | 32 | — | 0 | 675 |
| 2019 | 25 | — | 1 | 561 |
| 2020 | 21 | — | 0 | 430 |
| 2021 | 13 | — | 0 | 329 |
| 2022 | 8 | — | 0 | 280 |
| 2023 | 8 | — | 0 | 207 |
| 2024 | 3 | — | 0 | 219 |
| 2025 | 2 | — | 0 | 111 |
| 2026 | 4 | — | 0 | — |
https://510kreport.com/device/P020009 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020009: Express/Express 2 MR & Otw Coronary Stent Systems.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P020009
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026