# P150012: Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead

- Pathway: PMA
- Applicant: Boston Scientific
- Decided: Apr 25, 2016 after 419 days
- Product code: LWP (Implantable Pulse Generator, Pacemaker (Non-Crt))
- Device class: 3
- Recalls of this device: 28 (14 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-1770-2026: 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-0084-2026: 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-0088-2026: 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-0095-2026: 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-0081-2026: 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-0091-2026: 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-0082-2026: 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-0089-2026: 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-0094-2026: 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-0097-2026: 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-0822-2025: 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-0824-2025: 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-0823-2025: 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 II · Z-1998-2021: 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 I · Z-2017-2021: 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-1999-2021: 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-2000-2021: 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-3256-2018: 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-3257-2018: 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-3255-2018: 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-0370-2018: 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-0358-2018: 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-0359-2018: 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-0369-2018: 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-0377-2018: 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-0357-2018: 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
- Nov 30, 2016 · Class II · Z-0938-2017: Boston Scientific is conducting a recall on Boston Scientific INGEVITY" MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely
- Jun 15, 2016 · Class II · Z-2749-2016: Five Accolate MRI and Essentio MRI DR pulse generators with an alternate MICS module configuration were shipped to US customers and implanted. This alternate configuration did not receive FDA approval

Source page: https://510kreport.com/device/P150012
Methodology: https://510kreport.com/methodology