PMA · Approved
Recalled · Class II · 2018Cadence (R) Tiered Therapy Defibrillation 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 Apr 30, 1993 through premarket approval, which rests on the device’s own clinical evidence after a 738-day review. 2 later devices descend from it. It has been recalled 40 times.
- Decided
- Apr 30, 1993
- Review
- 738 days
- Class
- Class III
- Product code
- LWS
- Recalls
- 40
2 later devices descend from it, 1 citing it directly.
- This deviceP910023 Cadence (R) Tiered Therapy Defibrillation SystemAbbott Medical · 1993
- 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 · 2 generations on · 0 of its ownK101982 Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter…St Jude Medical, Crmd · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P910023 | Cadence (R) Tiered Therapy Defibrillation System | Abbott Medical | 1993 | — |
| +1 | K093858 | Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A | St. Jude Medical, Cardiac Rhythm Management Divisi | 2010 | — |
| +2 | K101982 | Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 | St Jude Medical, Crmd | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 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.
Planning a device in LWS? 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093858 | Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2018 | Class II | Z-2320-2018 | Software design | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against… |
| Apr 16, 2018 | Class II | Z-2325-2018 | Software design | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against… |
| Apr 16, 2018 | Class II | Z-2321-2018 | Software design | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against… |
| Apr 16, 2018 | Class II | Z-2318-2018 | Software design | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against… |
| Apr 16, 2018 | Class II | Z-2319-2018 | Software design | The firm is releasing new firmware for high voltage implantable cardiac devices (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) intended to strengthen security by providing an additional layer of protection against… |
| Mar 31, 2016 | Class II | Z-1632-2016 | Other | St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy. |
| Aug 19, 2014 | Class II | Z-2572-2014 | Component design/selection | An anomaly may result in delayed, partial, or no delivery of high voltage therapy. Internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high… |
| Jan 16, 2008 | Not classified | Z-1327-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1341-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1336-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1347-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1340-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1335-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1333-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1323-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1325-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1339-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1346-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1324-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1344-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1330-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1326-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1345-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1331-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1328-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1337-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1329-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1343-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1321-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1338-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1334-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1320-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1322-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1332-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Jan 16, 2008 | Not classified | Z-1342-2008 | Software design | A condition that could lead to a ventricular sensing anomaly in Epic and Atlas family of lmplantable Cardioverter Defibrillators (ICDs) has been identified. A loss of ventricular sensing would prevent the ICD from being able to detect an… |
| Oct 6, 2005 | Not classified | Z-0149-06 | Other | Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support. |
| Oct 6, 2005 | Not classified | Z-0146-06 | Other | Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support. |
| Oct 6, 2005 | Not classified | Z-0150-06 | Other | Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support. |
| Oct 6, 2005 | Not classified | Z-0147-06 | Other | Vendor-supplied memory chip in a limited number of St. Jude Medical ICDs can trigger a temporary loss of pacing function and permanent los of defibrillation support. |
| Mar 10, 2005 | Not classified | Z-0709-05 | Other | Sensitivity of a magnetic switch was not being set correctly. This could result in delivery of an unneeded shock during surgery with use of electrocautery. |
The 5 latest of 40 recalls; the web page lists all.
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
2007high 168 (2014) · low 70 (2007)2026
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
2007high 8 (2009) · low 0 (2014)2026
Class I (12 since 2007) Class II/III not classified
Adverse event reports per year · LWS
24,303in 2025
2007high 28,701 (2023) · low 10,330 (2007)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/P910023 · printed Nov 6, 2026
Cite this page
510(k) Report. “P910023: Cadence (R) Tiered Therapy Defibrillation System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P910023
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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