# P910023: Cadence (R) Tiered Therapy Defibrillation System

- Pathway: PMA
- Applicant: Abbott Medical
- Decided: Apr 30, 1993 after 738 days
- Product code: LWS (Implantable Cardioverter Defibrillator (Non-Crt))
- Device class: 3
- Recalls of this device: 40 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- 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-2320-2018: 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-2325-2018: 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-2321-2018: 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-2318-2018: 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-2319-2018: 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
- Mar 31, 2016 · Class II · Z-1632-2016: 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: 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 
- 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
- Oct 6, 2005 · Not classified · Z-0149-06: 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: 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: 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: 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: 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/P910023
Methodology: https://510kreport.com/methodology