PMA · Approved
Recalled · Class II · 2021DiamondTemp Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Approved on Jan 28, 2021 through premarket approval, which rests on the device’s own clinical evidence after a 227-day review. It has been recalled 6 times.
- Decided
- Jan 28, 2021
- Review
- 227 days
- Class
- Class III
- Product code
- OAE
- Recalls
- 6
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P200028 has 24 supplements since 2021: 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 |
|---|---|
| 2021 | 7 |
| 2022 | 7 |
| 2023 | 7 |
| 2024 | 2 |
| 2025 | 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 OAE? 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 |
|---|---|---|---|---|
| Feb 22, 2021 | Class II | Z-1320-2021 | Under Investigation by firm | It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation… |
| Feb 22, 2021 | Class II | Z-1322-2021 | Under Investigation by firm | It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation… |
| Feb 22, 2021 | Class II | Z-1318-2021 | Under Investigation by firm | It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation… |
| Feb 22, 2021 | Class II | Z-1317-2021 | Under Investigation by firm | It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation… |
| Feb 22, 2021 | Class II | Z-1319-2021 | Under Investigation by firm | It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation… |
| Feb 22, 2021 | Class II | Z-1321-2021 | Under Investigation by firm | It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter of the catheter. This could result in blood stagnation… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All OAE devicesOAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OAE
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAE
Too few OAE 510(k)s in any year since 2007 to give a median.
Recalls per year · OAE
5in 2025
Class I (12 since 2007) Class II/III not classified
Adverse event reports per year · OAE
1,412in 2025
MAUDE reports naming product code OAE, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 5 | 0 |
| 2011 | 14 | — | 1 | 69 |
| 2012 | 10 | — | 0 | 70 |
| 2013 | 10 | — | 0 | 111 |
| 2014 | 15 | — | 0 | 131 |
| 2015 | 15 | — | 0 | 274 |
| 2016 | 19 | — | 0 | 311 |
| 2017 | 15 | — | 0 | 387 |
| 2018 | 28 | — | 0 | 884 |
| 2019 | 34 | — | 1 | 908 |
| 2020 | 27 | — | 0 | 744 |
| 2021 | 31 | — | 0 | 914 |
| 2022 | 26 | — | 2 | 1,161 |
| 2023 | 43 | — | 1 | 1,311 |
| 2024 | 32 | — | 7 (7) | 2,098 |
| 2025 | 20 | — | 5 (5) | 1,412 |
| 2026 | 25 | — | 0 | — |
https://510kreport.com/device/P200028 · printed Nov 6, 2026
Cite this page
510(k) Report. “P200028: DiamondTemp Ablation System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P200028
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026