PMA · Approved
Recalled · Class II · 2018Chilli Cooled RF Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · LPB Cardiac Ablation Percutaneous Catheter
Approved on Feb 2, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 368-day review. It has been recalled 4 times.
- Decided
- Feb 2, 1999
- Review
- 368 days
- Class
- Class III
- Product code
- LPB
- Recalls
- 4
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P980003 has 90 supplements since 1999: 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 |
|---|---|
| 1999 | 2 |
| 2002 | 2 |
| 2003 | 3 |
| 2004 | 4 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 2 |
| 2010 | 2 |
| 2011 | 8 |
| 2012 | 5 |
| 2013 | 7 |
| 2014 | 10 |
| 2015 | 7 |
| 2016 | 6 |
| 2017 | 12 |
| 2018 | 4 |
| 2019 | 4 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 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 LPB? 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 |
|---|---|---|---|---|
| Jun 20, 2018 | Class II | Z-0202-2019 | — | Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released. |
| Sep 27, 2010 | Not classified | Z-0170-2011 | Packaging | Boston Scientific is conducting a Recall on CircuCool Tubing Sets used with the Chilli II Cooled Ablation System because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the… |
| Sep 22, 2009 | Not classified | Z-1156-2010 | Nonconforming Material/Component | Product failure-- Product may cease operation as a result of potential speed control board failure when the device is shut off, and may not turn back on. A component on the circuit board fails unexpectedly because of a power surge… |
| Dec 30, 2005 | Not classified | Z-0473-06 | Other | Product is mislabeled with the incorrect catheter curve description. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LPB devicesLPB Cardiac Ablation Percutaneous Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LPB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPB
Too few LPB 510(k)s in any year since 2007 to give a median.
Recalls per year · LPB
6in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPB
1,190in 2025
MAUDE reports naming product code LPB, 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 | 22 | — | 0 | 61 |
| 2008 | 20 | — | 4 | 75 |
| 2009 | 31 | — | 2 | 76 |
| 2010 | 45 | — | 1 | 63 |
| 2011 | 57 | — | 4 | 102 |
| 2012 | 38 | — | 0 | 248 |
| 2013 | 63 | — | 0 | 406 |
| 2014 | 85 | — | 1 | 799 |
| 2015 | 85 | — | 0 | 1,189 |
| 2016 | 54 | — | 0 | 1,010 |
| 2017 | 46 | — | 6 | 1,115 |
| 2018 | 35 | — | 0 | 975 |
| 2019 | 30 | — | 0 | 1,124 |
| 2020 | 33 | — | 0 | 1,182 |
| 2021 | 39 | — | 0 | 1,240 |
| 2022 | 25 | — | 0 | 1,336 |
| 2023 | 22 | — | 0 | 1,500 |
| 2024 | 18 | — | 0 | 1,839 |
| 2025 | 15 | — | 0 | 1,190 |
| 2026 | 8 | — | 0 | — |
https://510kreport.com/device/P980003 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980003: Chilli Cooled RF Ablation System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980003
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026