PMA · Approved
Recalled · Class II · 2022Biosense Webster Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosense Webster, Inc. · OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Approved on Nov 5, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 466-day review. It has been recalled 8 times.
- Decided
- Nov 5, 2004
- Review
- 466 days
- Class
- Class III
- Product code
- OAD
- Recalls
- 8
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P030031 has 135 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 | 2 |
| 2007 | 4 |
| 2008 | 4 |
| 2009 | 7 |
| 2010 | 7 |
| 2011 | 8 |
| 2012 | 8 |
| 2013 | 8 |
| 2014 | 8 |
| 2015 | 8 |
| 2016 | 7 |
| 2017 | 5 |
| 2018 | 8 |
| 2019 | 7 |
| 2020 | 8 |
| 2021 | 15 |
| 2022 | 4 |
| 2023 | 6 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 5 |
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 |
|---|---|---|---|---|
| Sep 7, 2022 | Class II | Z-0169-2023 | Process control | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip… |
| Oct 19, 2014 | Class II | Z-0139-2015 | Use error | The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. |
| Nov 22, 2010 | Not classified | Z-0979-2012 | Labeling design | Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary… |
| Nov 22, 2010 | Not classified | Z-0980-2012 | Labeling design | Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary… |
| Nov 22, 2010 | Not classified | Z-0981-2012 | Labeling design | Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary… |
| Nov 22, 2010 | Not classified | Z-0982-2012 | Labeling design | Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary… |
| Nov 22, 2010 | Not classified | Z-0983-2012 | Labeling design | Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary… |
| Aug 8, 2005 | Not classified | Z-0057-06 | Other | Increased complaints regarding catheters with leaks and flow obstruction. |
The 5 latest of 8 recalls; the web page lists all.
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/P030031 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030031: Biosense Webster Navistar/Celsius Thermo Cool Diagnostic/Ablation Deflectable Tip Catheters.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030031
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026