PMA · Approved
Recalled · 2009Therapy Dual 8 Cardiac Ablation System,Theram 8MM Thermister Ablation Catheter Safire TX Ablation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Irvine Biomedical,Inc.(Ibi) · OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Approved on Nov 18, 2005 through premarket approval, which rests on the device’s own clinical evidence after a 410-day review. It has been recalled 4 times.
- Decided
- Nov 18, 2005
- Review
- 410 days
- Class
- Class III
- Product code
- OAD
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P040042 has 57 supplements since 2005: 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 |
|---|---|
| 2005 | 1 |
| 2006 | 4 |
| 2007 | 6 |
| 2008 | 2 |
| 2009 | 3 |
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 4 |
| 2016 | 5 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 3 |
| 2020 | 4 |
| 2021 | 4 |
| 2022 | 3 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 3 |
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 OAD? 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 25, 2009 | Not classified | Z-0594-2010 | Process design | This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard… |
| Nov 25, 2009 | Not classified | Z-0593-2010 | Process design | This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. If this occurs, treatment may be delayed or interrupted. The firm's initial health hazard… |
| Nov 8, 2006 | Not classified | Z-0310-2007 | Other | Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair. |
| Nov 8, 2006 | Not classified | Z-0309-2007 | Other | Recall was initiated after a clinical incident involving separation of the front sheath, preventing deployment of the stent graft. This required the physician to convert the patient to conventional open repair. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All OAD devicesOAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OAD
19in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAD
Too few OAD 510(k)s in any year since 2007 to give a median.
Recalls per year · OAD
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAD
196in 2025
MAUDE reports naming product code OAD, 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 | 14 | — | 0 | 2 |
| 2008 | 8 | — | 0 | 43 |
| 2009 | 9 | — | 2 | 94 |
| 2010 | 12 | — | 0 | 407 |
| 2011 | 21 | — | 0 | 486 |
| 2012 | 19 | — | 1 | 414 |
| 2013 | 30 | — | 2 | 256 |
| 2014 | 25 | — | 0 | 329 |
| 2015 | 24 | — | 4 | 274 |
| 2016 | 47 | — | 0 | 239 |
| 2017 | 64 | — | 0 | 403 |
| 2018 | 29 | — | 4 | 423 |
| 2019 | 39 | — | 0 | 475 |
| 2020 | 42 | — | 0 | 389 |
| 2021 | 50 | — | 0 | 402 |
| 2022 | 20 | — | 1 | 344 |
| 2023 | 19 | — | 0 | 319 |
| 2024 | 19 | — | 0 | 290 |
| 2025 | 19 | — | 0 | 196 |
| 2026 | 14 | — | 1 | — |
https://510kreport.com/device/P040042 · printed Nov 6, 2026
Cite this page
510(k) Report. “P040042: Therapy Dual 8 Cardiac Ablation System,Theram 8MM Thermister Ablation Catheter Safire TX Ablation Catheter.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P040042
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026