PMA · Approved
Recalled · 2008Amplatzer Duct Occluder and 180 Degree Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · MAE Occluder, Patent Ductus, Arteriosus
Approved on May 14, 2003 through premarket approval, which rests on the device’s own clinical evidence after a 324-day review. It has been recalled 5 times.
- Decided
- May 14, 2003
- Review
- 324 days
- Class
- Class III
- Product code
- MAE
- Recalls
- 5
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P020024 has 65 supplements since 2003: 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 |
|---|---|
| 2003 | 1 |
| 2005 | 3 |
| 2006 | 5 |
| 2007 | 6 |
| 2008 | 3 |
| 2009 | 3 |
| 2010 | 4 |
| 2011 | 3 |
| 2012 | 2 |
| 2013 | 3 |
| 2014 | 1 |
| 2016 | 6 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 6 |
| 2020 | 6 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 3 |
| 2025 | 1 |
| 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 MAE? 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 25, 2008 | Not classified | Z-2192-2008 | Packaging process control | AGA Medical Corporation has identified an issue with outer pouch seal integrity within one production lot of 10 French 45/80 delivery systems and one lot of 24 mm Sizing Balloon. We have not observed incomplete seals with the inner pouch.… |
| Oct 2, 2006 | Not classified | Z-0255-2007 | Other | AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier.… |
| Oct 2, 2006 | Not classified | Z-0256-2007 | Other | AGA Medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. These microscopic tears are a potential breach of the sterile barrier.… |
| Sep 6, 2005 | Not classified | Z-0461-06 | Other | The pointed end of a screw securing the occluder to the delivery cable could scrape off microscopic fragments of the polytetrafluorethylene (PTFE) plastic lining of the sheath. Those shavings could potentially migrate into a patient's… |
| Nov 23, 2004 | Not classified | Z-0350-05 | Other | Tubing utilized in the manufacture of the AMPLATZER Delivery and Exchange System sheaths and dilators was in some cases manufactured by our supplier outside of process parameters; causing a residue to be left on the inside of the tubing. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All MAE devicesMAE Occluder, Patent Ductus, Arteriosus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAE
Too few MAE 510(k)s in any year since 2007 to give a median.
Recalls per year · MAE
No recall names MAE since 2007.
Adverse event reports per year · MAE
178in 2025
MAUDE reports naming product code MAE, 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 | 13 | — | 0 | 2 |
| 2008 | 6 | — | 0 | 12 |
| 2009 | 9 | — | 0 | 15 |
| 2010 | 7 | — | 0 | 18 |
| 2011 | 7 | — | 0 | 18 |
| 2012 | 6 | — | 0 | 19 |
| 2013 | 5 | — | 0 | 16 |
| 2014 | 3 | — | 0 | 28 |
| 2015 | 2 | — | 0 | 24 |
| 2016 | 10 | — | 0 | 12 |
| 2017 | 3 | — | 0 | 23 |
| 2018 | 1 | — | 0 | 28 |
| 2019 | 6 | — | 0 | 53 |
| 2020 | 6 | — | 0 | 109 |
| 2021 | 1 | — | 0 | 76 |
| 2022 | 1 | — | 0 | 80 |
| 2023 | 1 | — | 0 | 127 |
| 2024 | 4 | — | 0 | 117 |
| 2025 | 1 | — | 0 | 178 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P020024 · printed Nov 6, 2026
Cite this page
510(k) Report. “P020024: Amplatzer Duct Occluder and 180 Degree Delivery System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P020024
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026