PMA · Approved
Recalled · Class II · 2018ST Jude Medical Epic HF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Medical · NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Approved on Jun 30, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 194-day review. 6 later devices descend from it. It has been recalled 35 times.
- Decided
- Jun 30, 2004
- Review
- 194 days
- Class
- Class III
- Product code
- NIK
- Recalls
- 35
6 later devices descend from it, 4 citing it directly.
- This deviceP030054 ST Jude Medical Epic HF SystemAbbott Medical · 2004
- 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 · cites it directly · 0 of its ownK113773 ST Jude Medical, IS4 Flushing/Funneling ToolSt Jude Medical · 2012
- Descendant · 2 generations on · 0 of its ownK101982 Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter…St Jude Medical, Crmd · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
2008high 2 (2010) · low 0 (2011)2026
Most influential descendants
Showing 5 of 6 · 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
- K113773ST Jude Medical, IS4 Flushing/Funneling ToolSt Jude Medical · 2012 · cites it directly0descendants
- K101982Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180St Jude Medical, Crmd · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P030054 | ST Jude Medical Epic HF System | Abbott Medical | 2004 | — |
| +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 | — |
| +1 | K113773 | ST Jude Medical, IS4 Flushing/Funneling Tool | St Jude Medical | 2012 | — |
| +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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 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.
Planning a device in NIK? 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? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-2327-2018 | 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-2324-2018 | 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-2328-2018 | 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-2322-2018 | 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-2323-2018 | 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-2326-2018 | 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… |
| 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… |
| 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 35 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 NIK devicesNIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NIK
56in 2025
2007high 112 (2017) · low 43 (2009)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · NIK
Too few NIK 510(k)s in any year since 2007 to give a median.
Recalls per year · NIK
1in 2022
2007high 9 (2007) · low 0 (2011)2026
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · NIK
10,855in 2025
2007high 16,265 (2017) · low 924 (2007)2025
MAUDE reports naming product code NIK, 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 | 53 | — | 9 | 924 |
| 2008 | 62 | — | 1 | 3,021 |
| 2009 | 43 | — | 2 | 4,177 |
| 2010 | 51 | — | 7 | 5,668 |
| 2011 | 50 | — | 0 | 5,944 |
| 2012 | 83 | — | 2 | 5,582 |
| 2013 | 50 | — | 0 | 7,373 |
| 2014 | 76 | — | 0 | 10,731 |
| 2015 | 49 | — | 0 | 7,828 |
| 2016 | 109 | — | 2 (1) | 13,255 |
| 2017 | 112 | — | 9 (5) | 16,265 |
| 2018 | 91 | — | 0 | 8,348 |
| 2019 | 62 | — | 0 | 7,266 |
| 2020 | 75 | — | 3 | 9,609 |
| 2021 | 67 | — | 0 | 10,134 |
| 2022 | 62 | — | 1 | 10,646 |
| 2023 | 58 | — | 0 | 11,897 |
| 2024 | 56 | — | 0 | 11,697 |
| 2025 | 56 | — | 0 | 10,855 |
| 2026 | 44 | — | 0 | — |
https://510kreport.com/device/P030054 · printed Nov 4, 2026
Cite this page
510(k) Report. “P030054: ST Jude Medical Epic HF System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P030054
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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