PMA · Approved
Recalled · Class I · 2026Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · LWP Implantable Pulse Generator, Pacemaker (Non-Crt)
Approved on Apr 25, 2016 through premarket approval, which rests on the device’s own clinical evidence after a 419-day review. It has a Class I recall. It has been recalled 28 times, including 14 Class I recalls.
- Decided
- Apr 25, 2016
- Review
- 419 days
- Class
- Class III
- Product code
- LWP
- Recalls
- 28 (14 Class I)
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P150012 has 186 supplements since 2016: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
2016high 29 (2017) · low 9 (2025)2026
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2016 | 20 |
| 2017 | 29 |
| 2018 | 15 |
| 2019 | 21 |
| 2020 | 17 |
| 2021 | 17 |
| 2022 | 17 |
| 2023 | 15 |
| 2024 | 10 |
| 2025 | 9 |
| 2026 | 16 |
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.
1 device in this family has a Class I recall. 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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 19, 2026 | Class I | Z-1770-2026 | Nonconforming Material/Component | 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 population is expanding to include all… |
| Aug 20, 2025 | Class I | Z-0084-2026 | Other | 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 which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0088-2026 | Other | 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 which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0095-2026 | Other | 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 which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0081-2026 | Other | 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 which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0091-2026 | Other | 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 which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0082-2026 | Other | 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 which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0089-2026 | Other | 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 which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0094-2026 | Other | 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 which includes ACCOLADE, PROPONENT… |
| Aug 20, 2025 | Class I | Z-0097-2026 | Other | 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 which includes ACCOLADE, PROPONENT… |
| Dec 12, 2024 | Class I | Z-0822-2025 | Process design | 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 operations due to latent high battery… |
| Dec 12, 2024 | Class I | Z-0824-2025 | Process design | 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 operations due to latent high battery… |
| Dec 12, 2024 | Class I | Z-0823-2025 | Process design | 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 operations due to latent high battery… |
| Jun 3, 2021 | Class II | Z-1998-2021 | Nonconforming Material/Component | 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 battery and associated progression of… |
| Jun 3, 2021 | Class I | Z-2017-2021 | Device Design | 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) when the device's battery exhibits… |
| Jun 3, 2021 | Class II | Z-1999-2021 | Nonconforming Material/Component | 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 battery and associated progression of… |
| Jun 3, 2021 | Class II | Z-2000-2021 | Nonconforming Material/Component | 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 battery and associated progression of… |
| Sep 10, 2018 | Class II | Z-3256-2018 | Component design/selection | 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 | Component design/selection | 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 | Component design/selection | 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 | Device Design | 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 pacemaker systems (pacemakers). |
| Dec 7, 2017 | Class II | Z-0358-2018 | Device Design | 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 pacemaker systems (pacemakers). |
| Dec 7, 2017 | Class II | Z-0359-2018 | Device Design | 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 pacemaker systems (pacemakers). |
| Dec 7, 2017 | Class II | Z-0369-2018 | Device Design | 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 pacemaker systems (pacemakers). |
| Dec 7, 2017 | Class II | Z-0377-2018 | Device Design | 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 pacemaker systems (pacemakers). |
| Dec 7, 2017 | Class II | Z-0357-2018 | Device Design | 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 pacemaker systems (pacemakers). |
| Nov 30, 2016 | Class II | Z-0938-2017 | Process control | 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 connected to the lead body. |
| Jun 15, 2016 | Class II | Z-2749-2016 | Process control | 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 yet. |
The 5 latest of 28 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LWP devicesLWP Implantable Pulse Generator, Pacemaker (Non-Crt): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LWP
46in 2025
2007high 126 (2014) · low 46 (2025)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · LWP
Too few LWP 510(k)s in any year since 2007 to give a median.
Recalls per year · LWP
21in 2025
2007high 21 (2017) · low 0 (2011)2026
Class I (26 since 2007) Class II/III not classified
Adverse event reports per year · LWP
11,931in 2025
2007high 14,936 (2018) · low 49 (2007)2025
MAUDE reports naming product code LWP, 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 | 58 | — | 7 | 49 |
| 2008 | 87 | — | 2 | 496 |
| 2009 | 78 | — | 8 | 805 |
| 2010 | 66 | — | 7 | 678 |
| 2011 | 91 | — | 0 | 684 |
| 2012 | 123 | — | 0 | 1,087 |
| 2013 | 116 | — | 2 | 5,164 |
| 2014 | 126 | — | 2 | 9,400 |
| 2015 | 97 | — | 2 | 9,422 |
| 2016 | 97 | — | 1 | 12,354 |
| 2017 | 116 | — | 21 | 11,643 |
| 2018 | 97 | — | 0 | 14,936 |
| 2019 | 88 | — | 0 | 9,627 |
| 2020 | 90 | — | 0 | 8,989 |
| 2021 | 70 | — | 0 | 9,374 |
| 2022 | 65 | — | 0 | 14,286 |
| 2023 | 54 | — | 0 | 12,633 |
| 2024 | 58 | — | 4 (4) | 10,495 |
| 2025 | 46 | — | 21 (21) | 11,931 |
| 2026 | 40 | — | 1 (1) | — |
https://510kreport.com/device/P150012 · printed Nov 6, 2026
Cite this page
510(k) Report. “P150012: Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P150012
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026