PMA · Approved
Recalled · Class II · 2023Tacticath Quartz Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Approved on Oct 24, 2014 through premarket approval, which rests on the device’s own clinical evidence after a 329-day review. It has been recalled 6 times.
- Decided
- Oct 24, 2014
- Review
- 329 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.
P130026 has 99 supplements since 2015: 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 |
|---|---|
| 2015 | 10 |
| 2016 | 11 |
| 2017 | 3 |
| 2018 | 9 |
| 2019 | 18 |
| 2020 | 11 |
| 2021 | 10 |
| 2022 | 7 |
| 2023 | 6 |
| 2024 | 4 |
| 2025 | 4 |
| 2026 | 6 |
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 |
|---|---|---|---|---|
| Dec 18, 2023 | Class II | Z-0814-2024 | Under Investigation by firm | When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific… |
| Mar 24, 2022 | Class II | Z-0956-2022 | Process control | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. |
| Mar 24, 2022 | Class II | Z-0957-2022 | Process control | Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. |
| May 22, 2020 | Class II | Z-2541-2020 | Process control | High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter |
| Apr 5, 2019 | Class II | Z-1493-2019 | Software design | In reported cases, the device log on the TactiSys Quartz Equipment operating on Software Version 1.7.0 fills the allocated disk space, which prevents the storage of new log data. This may lead to intermittent contact force data to be… |
| Nov 25, 2014 | Class II | Z-1284-2015 | Software design | A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters. |
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. 2014, 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/P130026 · printed Nov 6, 2026
Cite this page
510(k) Report. “P130026: Tacticath Quartz Set.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P130026
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026