# P030054: ST Jude Medical Epic HF System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Jun 30, 2004 after 194 days
- Product code: NIK (Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D))
- Device class: 3
- Recalls of this device: 35 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Most influential descendants
- K093858: Psa Cable, Models 4160 and 4161 and Psa Cable Adapter, Model 4053A (2010), 1 descendant of its own
- K090163: Stylet, Models 4060, 4062, 4064, 4090, 4091 and 4078 (2009), 1 descendant of its own
- K191469: Biotronik Stylets (2019), 0 descendants of its own
- K113773: ST Jude Medical, IS4 Flushing/Funneling Tool (2012), 0 descendants of its own
- K101982: Merlin Psa Patient Cable EX 3150, Cable Adapter EX3170, M Adapter EX3180 (2010), 0 descendants of its own

## Recalls of this device
- Apr 16, 2018 · Class II · Z-2327-2018: 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 addit
- Apr 16, 2018 · Class II · Z-2324-2018: 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 addit
- Apr 16, 2018 · Class II · Z-2328-2018: 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 addit
- Apr 16, 2018 · Class II · Z-2322-2018: 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 addit
- Apr 16, 2018 · Class II · Z-2323-2018: 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 addit
- Apr 16, 2018 · Class II · Z-2326-2018: 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 addit
- Jan 16, 2008 · Not classified · Z-1327-2008: 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
- Jan 16, 2008 · Not classified · Z-1341-2008: 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
- Jan 16, 2008 · Not classified · Z-1336-2008: 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
- Jan 16, 2008 · Not classified · Z-1347-2008: 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
- Jan 16, 2008 · Not classified · Z-1340-2008: 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
- Jan 16, 2008 · Not classified · Z-1335-2008: 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
- Jan 16, 2008 · Not classified · Z-1333-2008: 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
- Jan 16, 2008 · Not classified · Z-1323-2008: 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
- Jan 16, 2008 · Not classified · Z-1325-2008: 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
- Jan 16, 2008 · Not classified · Z-1339-2008: 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
- Jan 16, 2008 · Not classified · Z-1346-2008: 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
- Jan 16, 2008 · Not classified · Z-1324-2008: 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
- Jan 16, 2008 · Not classified · Z-1344-2008: 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
- Jan 16, 2008 · Not classified · Z-1330-2008: 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
- Jan 16, 2008 · Not classified · Z-1326-2008: 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
- Jan 16, 2008 · Not classified · Z-1345-2008: 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
- Jan 16, 2008 · Not classified · Z-1331-2008: 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
- Jan 16, 2008 · Not classified · Z-1328-2008: 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
- Jan 16, 2008 · Not classified · Z-1337-2008: 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
- Jan 16, 2008 · Not classified · Z-1329-2008: 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
- Jan 16, 2008 · Not classified · Z-1343-2008: 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
- Jan 16, 2008 · Not classified · Z-1321-2008: 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
- Jan 16, 2008 · Not classified · Z-1338-2008: 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
- Jan 16, 2008 · Not classified · Z-1334-2008: 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
- Jan 16, 2008 · Not classified · Z-1320-2008: 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
- Jan 16, 2008 · Not classified · Z-1322-2008: 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
- Jan 16, 2008 · Not classified · Z-1332-2008: 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
- Jan 16, 2008 · Not classified · Z-1342-2008: 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
- Mar 10, 2005 · Not classified · Z-0709-05: 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.

Source page: https://510kreport.com/device/P030054
Methodology: https://510kreport.com/methodology