# P030005: Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software

- Pathway: PMA
- Applicant: Guidant Corp.
- Decided: Jan 26, 2004 after 308 days
- Product code: NKE (Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P))
- Device class: 3
- Recalls of this device: 20 (11 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has a Class I recall.

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

## Recalls of this device
- Mar 19, 2026 · Class I · Z-1771-2026: Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory popul
- Aug 20, 2025 · Class I · Z-0103-2026: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices
- Aug 20, 2025 · Class I · Z-0101-2026: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices
- Aug 20, 2025 · Class I · Z-0104-2026: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices
- Aug 20, 2025 · Class I · Z-0105-2026: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices
- Aug 20, 2025 · Class I · Z-0102-2026: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices
- Dec 12, 2024 · Class I · Z-0826-2025: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power o
- Dec 12, 2024 · Class I · Z-0827-2025: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power o
- Jun 3, 2021 · Class I · Z-2019-2021: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator
- Jun 3, 2021 · Class I · Z-2018-2021: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator
- Jun 3, 2021 · Class I · Z-2020-2021: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Explant battery indicator
- Jun 3, 2021 · Class II · Z-2002-2021: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the batter
- Jun 3, 2021 · Class II · Z-2003-2021: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery depletion of the batter
- Sep 10, 2018 · Class II · Z-3259-2018: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
- Sep 10, 2018 · Class II · Z-3258-2018: Boston Scientific has identified a subset of active pacemaker and CRT-Ps systems with an elevated potential for early pacemaker replacement due to hydrogen-induced accelerated battery depletion.
- Dec 7, 2017 · Class II · Z-0365-2018: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemake
- Dec 7, 2017 · Class II · Z-0360-2018: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemake
- Dec 7, 2017 · Class II · Z-0361-2018: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemake
- Dec 7, 2017 · Class II · Z-0366-2018: Boston Scientific has received reports of intermittent over-sensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemake
- Jun 24, 2006 · Not classified · Z-1298-06: Guidant has determined that low-voltage capacitors from a single component supplier may malfunction in a manner that can lead to premature battery depletion without warning in the affected devices.

Source page: https://510kreport.com/device/P030005
Methodology: https://510kreport.com/methodology