PMA · Approved
Recalled · 2008Livewire (R) Cardiac Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St Jude Medical · LPB Cardiac Ablation Percutaneous Catheter
Approved on May 4, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 1,082-day review. It has been recalled once.
- Decided
- May 4, 1999
- Review
- 1,082 days
- Class
- Class III
- Product code
- LPB
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P960016 has 89 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 | 3 |
| 2000 | 2 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 3 |
| 2004 | 2 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 1 |
| 2009 | 4 |
| 2010 | 8 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 3 |
| 2014 | 6 |
| 2015 | 9 |
| 2016 | 10 |
| 2017 | 2 |
| 2018 | 5 |
| 2019 | 5 |
| 2020 | 5 |
| 2021 | 3 |
| 2022 | 1 |
| 2023 | 2 |
| 2025 | 1 |
| 2026 | 2 |
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 5, 2008 | Not classified | Z-2313-2008 | Labeling mix-ups | St. Jude Medical has initiated a recall of one lot of Livewire TC" Ablation Catheter. The product was mis-labelled as having an 8 mm tip instead of 4 mm tip. This could potentially result in elevated temperatures and formation of coagulum… |
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/P960016 · printed Nov 6, 2026
Cite this page
510(k) Report. “P960016: Livewire (R) Cardiac Ablation System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P960016
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026