PMA · Approved
Recalled · Class I · 2015TVL (TM) Lead System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · LWS Implantable Cardioverter Defibrillator (Non-Crt)
Approved on May 10, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 315-day review. 1 of the 6 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 3 times, including a Class I recall.
- Decided
- May 10, 1996
- Review
- 315 days
- Class
- Class III
- Product code
- LWS
- Recalls
- 3 (1 Class I)
5 later devices descend from it, 3 citing it directly. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- This deviceP950022 TVL (TM) Lead SystemAbbott Medical · 1996
- Descendant · cites it directly · 1 of its ownK093858 Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASt. Jude Medical, Cardiac Rhythm Management Divisi · 2010
- Descendant · cites it directly · 1 of its ownK090163 Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009
- Descendant · 2 generations on · 0 of its ownK191469 Biotronik StyletsBiotronik, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK101982 Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter…St Jude Medical, Crmd · 2010
- Descendant · cites it directly · 0 of its ownK080924 Mond Rvot Stylet Models 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi · 2008
Most influential descendants
Showing 5 of 5 · See all- K093858Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053ASt. Jude Medical, Cardiac Rhythm Management Divisi · 2010 · cites it directly1descendant
- K090163Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078St Jude Medical · 2009 · cites it directly1descendant
- K191469Biotronik StyletsBiotronik, Inc. · 2019 · 2 generations on0descendants
- K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd · 2010 · 2 generations on0descendants
- K080924Mond Rvot Stylet Models 4140, 4141, 4150, 4151St. Jude Medical, Cardiac Rhythm Management Divisi · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P950022 | TVL (TM) Lead System | Abbott Medical | 1996 | — |
| +1 | K093858 | Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A | St. Jude Medical, Cardiac Rhythm Management Divisi | 2010 | — |
| +1 | K090163 | Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078 | St Jude Medical | 2009 | — |
| +2 | K191469 | Biotronik Stylets | Biotronik, Inc. | 2019 | — |
| +2 | K101982 | Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 | St Jude Medical, Crmd | 2010 | — |
| +1 | K080924 | Mond Rvot Stylet Models 4140, 4141, 4150, 4151 | St. Jude Medical, Cardiac Rhythm Management Divisi | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2019 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2015 | Class I | Z-0660-2016 | Process control | Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil. |
| Nov 28, 2011 | Not classified | Z-0457-2012 | Device Design | St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors. |
| Nov 28, 2011 | Not classified | Z-0458-2012 | Device Design | The recall was initiated because St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093858 (St. Jude Medical, Cardiac Rhythm Management Divisi, 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LWS devicesLWS Implantable Cardioverter Defibrillator (Non-Crt): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LWS
97in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LWS
Too few LWS 510(k)s in any year since 2007 to give a median.
Recalls per year · LWS
2in 2025
Class I (12 since 2007) Class II/III not classified
Adverse event reports per year · LWS
24,303in 2025
MAUDE reports naming product code LWS, 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 | 70 | — | 4 | 10,330 |
| 2008 | 94 | — | 3 | 11,327 |
| 2009 | 80 | — | 8 | 13,768 |
| 2010 | 119 | — | 6 | 17,321 |
| 2011 | 136 | — | 8 | 15,097 |
| 2012 | 129 | — | 5 | 12,820 |
| 2013 | 148 | — | 1 | 17,242 |
| 2014 | 168 | — | 0 | 18,594 |
| 2015 | 100 | — | 2 (1) | 14,040 |
| 2016 | 145 | — | 2 (2) | 16,638 |
| 2017 | 162 | — | 7 (5) | 18,454 |
| 2018 | 142 | — | 1 | 17,228 |
| 2019 | 98 | — | 0 | 16,184 |
| 2020 | 125 | — | 6 (3) | 16,909 |
| 2021 | 111 | — | 0 | 19,654 |
| 2022 | 91 | — | 3 | 23,454 |
| 2023 | 101 | — | 2 | 28,701 |
| 2024 | 108 | — | 0 | 25,202 |
| 2025 | 97 | — | 2 (1) | 24,303 |
| 2026 | 93 | — | 0 | — |
https://510kreport.com/device/P950022 · printed Nov 6, 2026
Cite this page
510(k) Report. “P950022: TVL (TM) Lead System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950022
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026